Study NCT04092452
A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Submitted Date:  December 24, 2022 (v27)
Quality Control Review Has Not Concluded

Note: The results information displayed below has not completed the quality control (QC) review process. ClinicalTrials.gov must post results information for applicable clinical trials (ACTs) within 30 days of submission, even if the submission has not completed the QC review process. The study sponsor or investigator is responsible for ensuring the results information meets the QC review criteria.

This submission includes brief standardized QC review comments added by the National Library of Medicine (NLM). These comments indicate the location of apparent errors, deficiencies, or inconsistencies. For more information, see the Final Rule (42 CFR Part 11) Information page.
Open or close this module Study Identification
Unique Protocol ID: C2501007
Brief Title: A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Official Title: A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2022
Overall Status: Completed
Study Start: December 2, 2019
Primary Completion: January 10, 2022 [Actual]
Study Completion: January 10, 2022 [Actual]
First Submitted: September 15, 2019
First Submitted that
Met QC Criteria:		 September 15, 2019
First Posted: September 17, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: January 23, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing Period and a 4 week Follow up Period.
Detailed Description:
Open or close this module Conditions
Conditions: Acne Inversa
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
The treatment period is a parallel design
Number of Arms: 4
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 194 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort 1
PF-06650833
 Drug: PF-06650833
400 mg QD
Experimental: Cohort 2
PF-6700841
 Drug: PF-06700841
45 mg QD
Experimental: Cohort 3
PF-06826647
 Drug: PF-06826647
400 mg QD
Placebo Comparator: Cohort placebo
placebo
 Drug: Placebo
placebo
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
[ Time Frame: At week 16 ]

HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Secondary Outcome Measures:
1. Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).
[ Time Frame: At weeks 1, 2, 4, 6, 8, and 12 ]

HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
2. Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI).
[ Time Frame: At week 16 ]

This estimand was intended to provide difference between treated and placebo in proportion of participants with a total AN count of 0 or 1, or 0, 1 or 2, respectively at week 16. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
3. Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)].
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

The analysis of covariance (ANCOVA) model was implemented for statistical testing, which included terms of treatment group, the stratification factors, and the baseline value as the independent variable.
4. Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
5. Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
6. Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].
[ Time Frame: At weeks 4, 8, 12 and 16 ]

HS flare was defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
7. Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30) - at Worst and on Average, Respectively, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10.
8. Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst and on Average Respectively, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. The range of skin pain was from 0 to 10.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
9. Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale at Worst and on Average Respectively, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. The range of skin pain was from 0 to 10.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
10. Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI)
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

Erythema response was defined as achieving erythema score of 1 or 0 in all affected anatomic regions among participants who had an erythema score of 2 or more in at least 1 anatomic region at baseline. NRI for missing values which were related to withdrawal and all other events except for COVID-19. A four-point ordinal scale ranging was used: 0 (no redness), 1 (faint but discernible pink coloration), 2 (moderate red coloration), and 3 (very red or bright red coloration).
11. Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
[ Time Frame: From the first dose of study intervention up to week 16 ]

The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
12. Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
[ Time Frame: From the first dose of study intervention up to week 16 ]

The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
13. Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)
[ Time Frame: From the first dose of study intervention up to week 16 ]

The vital signs were measured included temperature (Oral, Tympanic, Axillary or Temporal), pulse rate (beats/min) and blood pressure (mmHg).
14. Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)
[ Time Frame: From the first dose of study intervention up to week 16 ]

Laboratory test abnormalities included hematology, chemistry, urinalysis and biomarker.
15. Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)
[ Time Frame: From the first dose of study intervention up to week 16 ]

ECG parameters included QT interval, QTc interval, PR interval, and QRS complex.
16. Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS)
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

When using MMRM analysis, only observed data were used and missing data were not imputed. The HS symptoms items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale. The MMRM was used to compare the difference of active treatments with placebo participants at each visit. The model was included the fixed effects of treatment, visit, treatment-by-visit interaction and baseline value, along with patient as a random effect.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
17. Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

When using MMRM analysis, only observed data were used and missing data were not imputed. The HS symptoms items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale. The MMRM was used to compare the difference of active treatments with placebo participants at each visit. The model was included the fixed effects of treatment, visit, treatment-by-visit interaction and baseline value, along with patient as a random effect.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
18. Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)
[ Time Frame: At weeks 4, 8, 12 and 16 ]

The DLQI is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale.

Quality Control Review Comment provided by the National Library of Medicine:

  1. More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent.
19. Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)
[ Time Frame: At weeks 4, 8, 12 and 16 ]

The DLQI is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
20. Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)
[ Time Frame: At weeks 4, 8, 12 and 16 ]

The DLQI is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life over the last week.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
21. Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)
[ Time Frame: At weeks 1, 2, 4, 6, 8, 12 and 16 ]

In summary statistics for pharmacokinetic, concentration values below the lower limit of quantification (LLOQ) was set to zero.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa

Exclusion Criteria:

  • History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
  • Infected with hepatitis B or hepatitis C viruses.
  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Open or close this module Contacts/Locations
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations: United States, Alabama
The University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
The University of Alabama at Birmingham Hospital Outreach Lab
Birmingham, Alabama, United States, 35249
The University of Alabama at Birmingham Investigation Drug Services Pharmacy
Birmingham, Alabama, United States, 35249
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Pacific Clinical Trials
Long Beach, California, United States, 90806
Keck School of Medicine of University of Southern California
Los Angeles, California, United States, 90033
UCSF Dermatology Clinic
San Francisco, California, United States, 94115
University of California San Francisco
San Francisco, California, United States, 94115
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States, 94118
Clinical Science Institute
Santa Monica, California, United States, 90404
United States, Connecticut
New England Research Associates, LLC
Bridgeport, Connecticut, United States, 06606
Dermatology Physicians of Connecticut
Shelton, Connecticut, United States, 06484
United States, Florida
Total Dermatology Care Center
Jacksonville, Florida, United States, 32204
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Olympian Clinical Research Largo Office
Largo, Florida, United States, 33770
University of Miami Hospital
Miami, Florida, United States, 33125
Tory Sullivan MD PA
North Miami Beach, Florida, United States, 33162
Renstar Medical Research
Ocala, Florida, United States, 34470
MidState Skin Institute
Ocala, Florida, United States, 34471
Renstar Medical Research
Ocala, Florida, United States, 34471
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, United States, 32174
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, United States, 33028
ForCare Clinical Research
Tampa, Florida, United States, 33613
Alliance Clinical Research of Tampa
Tampa, Florida, United States, 33615
United States, Georgia
MedaPhase Inc.
Newnan, Georgia, United States, 30263
Advanced Medical Research PC
Sandy Springs, Georgia, United States, 30328
Georgia Skin Cancer and Aesthetic Dermatology
Watkinsville, Georgia, United States, 30677
United States, Illinois
NorthShore University HealthSystem Dermatology Clinic
Skokie, Illinois, United States, 60077
United States, Indiana
Ds Research
Clarksville, Indiana, United States, 47129
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
United States, Kentucky
DS Research
Louisville, Kentucky, United States, 40241
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Boston University General Clinical Research Unit
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University / Integrative Biosciences Center
Detroit, Michigan, United States, 48202
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
United States, Minnesota
Clinical Research Unit
Minneapolis, Minnesota, United States, 55455
Lillihei Clinical Research Unit
Minneapolis, Minnesota, United States, 55455
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States, 55455
United States, Missouri
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
Saint Louis University - Department of Dermatology
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Skin Specialists PC
Omaha, Nebraska, United States, 68144
United States, Nevada
J Woodson Clinical Studies Group
Henderson, Nevada, United States, 89052
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Oklahoma
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Penn State Health Radiology - University Physician Center
Hershey, Pennsylvania, United States, 17033
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, United States, 19103
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Dermatology and Skin Cancer Consultants
Humboldt, Tennessee, United States, 38343
Clinical Research Solutions
Jackson, Tennessee, United States, 38305
Dermatology and Skin Cancer Consultants
Jackson, Tennessee, United States, 38305
United States, Texas
Arlington Research Center
Arlington, Texas, United States, 76011
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78660
United States, Utah
University of Utah MidValley Dermatology
Murray, Utah, United States, 84107
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
Bellevue Dermatology Clinical Research Center
Bellevue, Washington, United States, 98004
Bellevue Dermatology Clinic
Bellevue, Washington, United States, 98004
Dermatology Associates of Seattle
Seattle, Washington, United States, 98101
Australia, Australian Capital Territory
Woden Dermatology
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Premier Specialists Pty Ltd
Kogarah, New South Wales, Australia, 2217
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
Australia, Queensland
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Skin Health Institute Inc.
Carlton, Victoria, Australia, 3053
Sinclair Dermatology
East Melbourne, Victoria, Australia, 3002
Canada
Centre de Recherche Saint-Louis
Quebec, Canada, G1W4R4
Alpha Recherche Clinique
Quebec, Canada, G2J 0C4
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada, L4M 7G1
Manna Research (London)
London, Ontario, Canada, N6A 2C2
DermEffects
London, Ontario, Canada, N6H 5L5
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
Canada, Quebec
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1L 0H8
Open or close this module IPDSharing
Plan to Share IPD: Yes
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Open or close this module References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: January 28, 2020
Uploaded: 12/24/2022 19:42
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: November 3, 2021
Uploaded: 12/24/2022 19:42
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details Participants were randomized at 60 sites in 3 countries, including Australia (N=6), United States (N=46) and Canada (N=8). A total of 194 participants (67% moderate and 33% severe hidradenitis suppurativa) were screened successfully and were randomized to 4 treatment groups.
 
Arm/Group Title Placebo PF-06650833 400mg QD PF-06700841 45mg QD PF-06826647 400mg QD
Arm/Group Description Participants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647. PF-06650833 400mg was administered orally once daily (QD) by tablet. PF-06700841 45mg was administered orally once daily (QD) by tablet. PF-06826647 400mg was administered orally once daily (QD) by tablet.
Period Title: Overall Study
Started 48 47 52 47
Completed [1] 35 30 37 31
Not Completed 13 17 15 16
Reason Not Completed
Adverse Event 1 3 3 7
Lack of Efficacy 1 1 1 0
Lost to Follow-up 4 3 5 1
Non-Compliance With Study Drug 0 0 1 1
Physician Decision 1 0 1 0
Pregnancy 2 0 0 0
Protocol Deviation 1 0 0 0
Withdrawal by Subject 3 10 3 5
Other 0 0 1 2
[1](treatment completed)
Open or close this module Baseline Characteristics
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QDTotal
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.Total of all reporting groups
Overall Number of Baseline Participants 48 47 52 47 194
Baseline Analysis Population Description
Age, Continuous
Mean (Standard Deviation)
Unit of measure: Years
Number Analyzed48 Participants47 Participants52 Participants47 Participants194 Participants
37.0(8.95)39.9(12.66)38.0(11.76)36.6(10.72)37.9(11.10)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed48 Participants47 Participants52 Participants47 Participants194 Participants
Female
42
87.5%
34
72.34%
40
76.92%
35
74.47%
151
77.84%
Male
6
12.5%
13
27.66%
12
23.08%
12
25.53%
43
22.16%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed48 Participants47 Participants52 Participants47 Participants194 Participants
Hispanic or Latino
7
14.58%
13
27.66%
7
13.46%
8
17.02%
35
18.04%
Not Hispanic or Latino
41
85.42%
34
72.34%
43
82.69%
38
80.85%
156
80.41%
Unknown or Not Reported
0
0%
0
0%
2
3.85%
1
2.13%
3
1.55%
Race/Ethnicity, Customized
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed48 Participants47 Participants52 Participants47 Participants194 Participants
White
32
66.67%
26
55.32%
26
50%
28
59.57%
112
57.73%
Black
13
27.08%
18
38.3%
24
46.15%
14
29.79%
69
35.57%
Asian
2
4.17%
0
0%
1
1.92%
3
6.38%
6
3.09%
American Indian or Alaska Native
1
2.08%
0
0%
1
1.92%
0
0%
2
1.03%
Multiracial (Asian, White)
0
0%
0
0%
0
0%
1
2.13%
1
0.52%
Not reported
0
0%
3
6.38%
0
0%
1
2.13%
4
2.06%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
Description HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame At week 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 46
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
33.3(22.2 to 45.5) 34.0(22.7 to 46.5) 51.9(39.7 to 64.0) 37.0(25.5 to 50.0)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsThe null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.4696
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.7
Confidence Interval(2-sided) 90%
-15.2 to 16.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.69
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsThe null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0298
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value18.7
Confidence Interval(2-sided) 90%
2.7 to 34.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.71
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsThe null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3606
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value3.5
Confidence Interval(2-sided) 90%
-12.6 to 19.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.79
Estimation Comments[Not specified]
2. Secondary Outcome:
Title Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).
Description HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame At weeks 1, 2, 4, 6, 8, and 12
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1
16.7(8.6 to 27.7) 12.8(5.7 to 22.7) 15.4(7.9 to 25.4) 21.3(12.0 to 32.2)
Week 2
25.0(15.1 to 36.9) 31.9(20.8 to 44.4) 32.0(21.2 to 43.4) 28.3(17.6 to 40.4)
Week 4
31.9(20.8 to 44.4) 40.4(28.3 to 53.5) 39.2(27.7 to 51.6) 27.7(17.2 to 40.3)
Week 6
37.5(26.4 to 50.0) 38.3(27.1 to 51.3) 44.2(32.4 to 56.3) 41.3(29.0 to 54.5)
Week 8
43.8(31.5 to 56.6) 36.2(25.1 to 48.7) 44.2(32.4 to 56.3) 41.3(29.0 to 54.5)
Week 12
41.7(29.6 to 54.5) 31.9(20.8 to 44.4) 50.0(37.9 to 62.1) 41.3(29.0 to 54.5)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-3.8
Confidence Interval(2-sided) 90%
-15.6 to 8.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.19
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.9
Confidence Interval(2-sided) 90%
-12.9 to 11.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.28
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value4.6
Confidence Interval(2-sided) 90%
-8.5 to 17.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.99
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.9
Confidence Interval(2-sided) 90%
-6.9 to 22.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.02
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.5
Confidence Interval(2-sided) 90%
-7.1 to 22.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.91
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value3.5
Confidence Interval(2-sided) 90%
-11.3 to 18.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.00
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value9.0
Confidence Interval(2-sided) 90%
-7.1 to 25.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.79
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.7
Confidence Interval(2-sided) 90%
-8.0 to 23.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.57
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.0
Confidence Interval(2-sided) 90%
-19.4 to 11.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.37
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.8
Confidence Interval(2-sided) 90%
-15.6 to 17.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.96
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value6.7
Confidence Interval(2-sided) 90%
-9.4 to 22.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.81
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value3.7
Confidence Interval(2-sided) 90%
-12.8 to 20.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.05
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7798
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-7.8
Confidence Interval(2-sided) 90%
-24.2 to 8.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.98
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.4819
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.5
Confidence Interval(2-sided) 90%
-15.9 to 16.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.92
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5933
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.4
Confidence Interval(2-sided) 90%
-19.2 to 14.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.19
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8421
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-9.9
Confidence Interval(2-sided) 90%
-26.1 to 6.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.81
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2090
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value8.0
Confidence Interval(2-sided) 90%
-8.2 to 24.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.85
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5183
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.5
Confidence Interval(2-sided) 90%
-17.1 to 16.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.12
Estimation Comments[Not specified]
3. Secondary Outcome:
Title Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI).
Description This estimand was intended to provide difference between treated and placebo in proportion of participants with a total AN count of 0 or 1, or 0, 1 or 2, respectively at week 16. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame At week 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
 
Total AN Count of 0 or 1
Number Analyzed Participants Participants Participants Participants
16.7(8.6 to 27.7) 17.0(8.8 to 28.3) 28.8(18.7 to 39.7) 23.9(15.1 to 35.0)
Total AN Count of 0, 1 or 2
Number Analyzed Participants Participants Participants Participants
22.9(14.4 to 34.0) 27.7(17.2 to 40.3) 38.5(27.1 to 50.0) 32.6(21.3 to 45.5)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsTotal AN Count of 0 or 1
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5150
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.3
Confidence Interval(2-sided) 90%
-12.7 to 12.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.54
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsTotal AN Count of 0 or 1
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0737
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value12.2
Confidence Interval(2-sided) 90%
-1.4 to 25.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.28
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsTotal AN Count of 0 or 1
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2081
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value6.6
Confidence Interval(2-sided) 90%
-6.7 to 20.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.11
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsTotal AN Count of 0, 1 or 2
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2957
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value4.8
Confidence Interval(2-sided) 90%
-9.9 to 19.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.90
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsTotal AN Count of 0, 1 or 2
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0456
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value15.6
Confidence Interval(2-sided) 90%
0.7 to 30.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.07
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsTotal AN Count of 0, 1 or 2
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1558
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value9.2
Confidence Interval(2-sided) 90%
-5.7 to 24.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.05
Estimation Comments[Not specified]
4. Secondary Outcome:
Title Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)].
Description The analysis of covariance (ANCOVA) model was implemented for statistical testing, which included terms of treatment group, the stratification factors, and the baseline value as the independent variable.
Time Frame At weeks 1, 2, 4, 6, 8, 12 and 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
 
Week 1
Number Analyzed Participants Participants Participants Participants
-1.94(-12.37 to 8.50) -13.92(-24.50 to -3.35) -17.00(-27.35 to -6.66) -19.39(-30.40 to -8.38)
Week 2
Number Analyzed Participants Participants Participants Participants
-22.29(-33.70 to -10.88) -34.81(-46.81 to -22.82) -25.15(-36.73 to -13.57) -27.79(-39.61 to -15.96)
Week 4
Number Analyzed Participants Participants Participants Participants
-26.46(-40.31 to -12.61) -30.98(-44.77 to -17.18) -44.00(-57.40 to -30.59) -30.38(-45.18 to -15.58)
Week 6
Number Analyzed Participants Participants Participants Participants
-33.05(-49.47 to -16.64) -25.96(-42.45 to -9.47) -47.62(-64.49 to -30.75) -42.00(-59.13 to -24.87)
Week 8
Number Analyzed Participants Participants Participants Participants
-36.26(-52.53 to -19.98) -24.76(-40.74 to -8.77) -52.41(-68.05 to -36.76) -51.33(-68.17 to -34.48)
Week 12
Number Analyzed Participants Participants Participants Participants
-32.52(-50.98 to -14.06) -39.06(-58.63 to -19.48) -49.70(-65.92 to -33.47) -52.51(-70.36 to -34.66)
Week 16
Number Analyzed Participants Participants Participants Participants
-34.96(-59.85 to -10.07) -24.11(-49.42 to 1.20) -52.58(-76.77 to -28.39) -44.37(-69.80 to -18.94)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Unit of Measure appears inconsistent with the Measure Title, the Measure Description, or both.
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-11.98
Confidence Interval(2-sided) 90%
-26.16 to 2.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.622
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-15.07
Confidence Interval(2-sided) 90%
-29.09 to -1.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.526
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-17.45
Confidence Interval(2-sided) 90%
-31.86 to -3.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.758
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-12.52
Confidence Interval(2-sided) 90%
-28.09 to 3.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.465
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.86
Confidence Interval(2-sided) 90%
-18.22 to 12.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.338
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-5.50
Confidence Interval(2-sided) 90%
-21.02 to 10.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.438
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.52
Confidence Interval(2-sided) 90%
-22.96 to 13.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.214
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-17.54
Confidence Interval(2-sided) 90%
-35.84 to 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.131
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-3.92
Confidence Interval(2-sided) 90%
-22.85 to 15.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.507
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.09
Confidence Interval(2-sided) 90%
-15.04 to 29.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.452
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-14.57
Confidence Interval(2-sided) 90%
-37.08 to 7.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.688
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.95
Confidence Interval(2-sided) 90%
-31.66 to 13.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.808
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8108
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value11.50
Confidence Interval(2-sided) 90%
-9.98 to 32.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.057
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1043
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.15
Confidence Interval(2-sided) 90%
-37.28 to 4.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.845
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1296
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-15.07
Confidence Interval(2-sided) 90%
-37.04 to 6.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.355
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3450
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.54
Confidence Interval(2-sided) 90%
-33.49 to 20.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.384
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1119
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-17.18
Confidence Interval(2-sided) 90%
-40.40 to 6.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.116
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0885
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-19.99
Confidence Interval(2-sided) 90%
-44.34 to 4.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.806
Estimation Comments[Not specified]
Statistical Analysis 19
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7050
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value10.85
Confidence Interval(2-sided) 90%
-22.28 to 43.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 20.140
Estimation Comments[Not specified]
Statistical Analysis 20
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1833
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-17.62
Confidence Interval(2-sided) 90%
-49.73 to 14.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 19.519
Estimation Comments[Not specified]
Statistical Analysis 21
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3213
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-9.41
Confidence Interval(2-sided) 90%
-42.76 to 23.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 20.277
Estimation Comments[Not specified]
5. Secondary Outcome:
Title Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
Description The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame At weeks 1, 2, 4, 6, 8, 12 and 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
 
Week 1 - Statistical Analysis (MI) - Absolute Score
Number Analyzed Participants Participants Participants Participants
22.9(19.6 to 26.1) 21.4(18.1 to 24.6) 20.8(17.7 to 24.0) 21.4(18.1 to 24.7)
Week 2 - Statistical Analysis (MI) - Absolute Score
Number Analyzed Participants Participants Participants Participants
18.9(15.8 to 22.1) 18.0(14.8 to 21.2) 18.8(15.7 to 21.9) 19.0(15.7 to 22.2)
Week 4 - Statistical Analysis (MI) - Absolute Score
Number Analyzed Participants Participants Participants Participants
17.9(14.8 to 20.9) 17.5(14.4 to 20.6) 16.5(13.6 to 19.5) 13.3(10.0 to 16.7)
Week 6 - Statistical Analysis (MI) - Absolute Score
Number Analyzed Participants Participants Participants Participants
19.7(16.0 to 23.3) 18.1(14.4 to 21.7) 14.9(11.4 to 18.5) 14.2(10.3 to 18.1)
Week 8 - Statistical Analysis (MI) - Absolute Score
Number Analyzed Participants Participants Participants Participants
14.9(11.5 to 18.3) 15.9(12.5 to 19.4) 15.0(11.7 to 18.4) 11.1(7.5 to 14.7)
Week 12 - Statistical Analysis (MI) - Absolute Score
Number Analyzed Participants Participants Participants Participants
15.8(12.6 to 18.9) 14.5(11.2 to 17.8) 13.0(10.0 to 16.0) 12.9(9.5 to 16.3)
Week 16 - Statistical Analysis (MI) - Absolute Score
Number Analyzed Participants Participants Participants Participants
16.0(12.4 to 19.6) 13.4(9.5 to 17.3) 12.0(8.8 to 15.3) 13.4(9.8 to 17.0)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.5
Confidence Interval(2-sided) 90%
-5.9 to 2.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.67
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.0
Confidence Interval(2-sided) 90%
-6.3 to 2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.60
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.5
Confidence Interval(2-sided) 90%
-5.9 to 2.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.68
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.9
Confidence Interval(2-sided) 90%
-5.2 to 3.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.59
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.1
Confidence Interval(2-sided) 90%
-4.3 to 4.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.55
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.0
Confidence Interval(2-sided) 90%
-4.3 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.61
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.3
Confidence Interval(2-sided) 90%
-4.5 to 3.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.51
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.3
Confidence Interval(2-sided) 90%
-5.4 to 2.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.48
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.5
Confidence Interval(2-sided) 90%
-8.8 to -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.58
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.6
Confidence Interval(2-sided) 90%
-6.5 to 3.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.99
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.7
Confidence Interval(2-sided) 90%
-9.5 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.91
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-5.4
Confidence Interval(2-sided) 90%
-10.5 to -0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.08
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6393
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value1.0
Confidence Interval(2-sided) 90%
-3.6 to 5.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.78
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5178
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.1
Confidence Interval(2-sided) 90%
-4.4 to 4.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.72
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0864
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-3.8
Confidence Interval(2-sided) 90%
-8.5 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.82
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3172
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.2
Confidence Interval(2-sided) 90%
-5.5 to 3.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.61
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1384
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.7
Confidence Interval(2-sided) 90%
-6.8 to 1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.51
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1427
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.8
Confidence Interval(2-sided) 90%
-7.2 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.66
Estimation Comments[Not specified]
Statistical Analysis 19
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1975
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.5
Confidence Interval(2-sided) 90%
-7.5 to 2.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.99
Estimation Comments[Not specified]
Statistical Analysis 20
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0755
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.0
Confidence Interval(2-sided) 90%
-8.5 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.76
Estimation Comments[Not specified]
Statistical Analysis 21
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16 - Statistical Analysis (MI) - Absolute Score
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1869
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.6
Confidence Interval(2-sided) 90%
-7.3 to 2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.89
Estimation Comments[Not specified]
6. Secondary Outcome:
Title Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
Description The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame At weeks 1, 2, 4, 6, 8, 12 and 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
 
Week 1 - Statistical Analysis (MI) - Percent Change from Baseline
Number Analyzed Participants Participants Participants Participants
-7.26(-17.77 to 3.26) -10.91(-21.57 to -0.25) -21.02(-31.75 to -10.30) -24.77(-35.94 to -13.59)
Week 2 - Statistical Analysis (MI) - Percent Change from Baseline
Number Analyzed Participants Participants Participants Participants
-26.58(-38.80 to -14.37) -30.87(-43.51 to -18.23) -28.63(-40.68 to -16.59) -26.41(-38.99 to -13.84)
Week 4 - Statistical Analysis (MI) - Percent Change from Baseline
Number Analyzed Participants Participants Participants Participants
-32.64(-45.55 to -19.72) -33.10(-45.56 to -20.65) -40.71(-52.76 to -28.66) -38.70(-52.26 to -25.14)
Week 6 - Statistical Analysis (MI) - Percent Change from Baseline
Number Analyzed Participants Participants Participants Participants
-30.57(-45.47 to -15.67) -34.10(-49.16 to -19.05) -46.83(-62.62 to -31.03) -43.09(-59.05 to -27.13)
Week 8 - Statistical Analysis (MI) - Percent Change from Baseline
Number Analyzed Participants Participants Participants Participants
-41.30(-54.94 to -27.67) -35.51(-49.04 to -21.98) -47.12(-60.38 to -33.85) -52.64(-67.14 to -38.14)
Week 12 - Statistical Analysis (MI) - Percent Change from Baseline
Number Analyzed Participants Participants Participants Participants
-36.46(-50.16 to -22.76) -43.24(-56.66 to -29.82) -53.03(-65.59 to -40.47) -50.11(-65.53 to -34.70)
Week 16 - Statistical Analysis (MI) - Percent Change from Baseline
Number Analyzed Participants Participants Participants Participants
-37.84(-54.85 to -20.82) -43.47(-60.47 to -26.47) -52.64(-70.79 to -34.49) -46.16(-64.20 to -28.11)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Unit of Measure appears inconsistent with the Measure Title, the Measure Description, or both.
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-3.65
Confidence Interval(2-sided) 90%
-17.90 to 10.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.659
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-13.77
Confidence Interval(2-sided) 90%
-28.16 to 0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.749
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-17.51
Confidence Interval(2-sided) 90%
-31.91 to -3.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.752
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.29
Confidence Interval(2-sided) 90%
-20.91 to 12.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.103
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.05
Confidence Interval(2-sided) 90%
-18.34 to 14.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.904
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.17
Confidence Interval(2-sided) 90%
-16.34 to 16.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.039
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.46
Confidence Interval(2-sided) 90%
-17.29 to 16.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.227
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.07
Confidence Interval(2-sided) 90%
-24.77 to 8.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.155
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.06
Confidence Interval(2-sided) 90%
-23.35 to 11.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.509
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-3.54
Confidence Interval(2-sided) 90%
-23.71 to 16.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.262
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.26
Confidence Interval(2-sided) 90%
-36.84 to 4.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.510
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-12.52
Confidence Interval(2-sided) 90%
-33.27 to 8.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.610
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7000
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value5.79
Confidence Interval(2-sided) 90%
-12.38 to 23.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.045
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2965
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-5.81
Confidence Interval(2-sided) 90%
-23.70 to 12.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.876
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1568
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-11.33
Confidence Interval(2-sided) 90%
-29.83 to 7.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.247
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2672
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.78
Confidence Interval(2-sided) 90%
-24.73 to 11.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.912
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0576
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.57
Confidence Interval(2-sided) 90%
-33.87 to 0.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.517
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1197
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-13.65
Confidence Interval(2-sided) 90%
-32.74 to 5.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.603
Estimation Comments[Not specified]
Statistical Analysis 19
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3388
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-5.63
Confidence Interval(2-sided) 90%
-27.91 to 16.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.545
Estimation Comments[Not specified]
Statistical Analysis 20
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 - Statistical Analysis (MI) - Percent Change from Baseline
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1376
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-14.80
Confidence Interval(2-sided) 90%
-37.12 to 7.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.567
Estimation Comments[Not specified]
Statistical Analysis 21
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2741
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.32
Confidence Interval(2-sided) 90%
-31.12 to 14.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.860
Estimation Comments[Not specified]
7. Secondary Outcome:
Title Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].
Description HS flare was defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame At weeks 4, 8, 12 and 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4
Number Analyzed Participants Participants Participants Participants
13.3(6.0 to 23.7) 11.9(5.9 to 22.7) 4.8(1.3 to 13.5) 14.3(7.1 to 26.0)
Week 8
Number Analyzed Participants Participants Participants Participants
9.3(4.1 to 18.9) 15.4(6.9 to 27.7) 2.3(0.2 to 9.4) 0(0.0 to 7.3)
Week 12
Number Analyzed Participants Participants Participants Participants
17.5(9.5 to 29.2) 5.9(1.6 to 16.9) 2.4(0.3 to 10.1) 0(0.0 to 8.2)
Week 16
Number Analyzed Participants Participants Participants Participants
17.1(7.7 to 30.2) 6.9(1.8 to 20.0) 0(0.0 to 7.3) 3.3(0.4 to 14.0)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.3
Confidence Interval(2-sided) 90%
-13.0 to 10.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.06
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.5
Confidence Interval(2-sided) 90%
-18.7 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.23
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value1.7
Confidence Interval(2-sided) 90%
-10.7 to 14.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.55
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8372
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value6.6
Confidence Interval(2-sided) 90%
-4.6 to 17.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.80
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0819
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.4
Confidence Interval(2-sided) 90%
-14.1 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.68
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0242
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.0
Confidence Interval(2-sided) 90%
-15.2 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.34
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0264
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-12.7
Confidence Interval(2-sided) 90%
-23.1 to -2.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.33
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0127
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-14.5
Confidence Interval(2-sided) 90%
-25.1 to -3.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.47
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0059
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.6
Confidence Interval(2-sided) 90%
-27.0 to -6.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.33
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1185
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-9.6
Confidence Interval(2-sided) 90%
-22.7 to 3.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.97
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0040
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.1
Confidence Interval(2-sided) 90%
-26.6 to -5.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.39
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0418
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-12.8
Confidence Interval(2-sided) 90%
-24.5 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.09
Estimation Comments[Not specified]
8. Secondary Outcome:
Title Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30) - at Worst and on Average, Respectively, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)
Description The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10.
Time Frame At weeks 1, 2, 4, 6, 8, 12 and 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 1 (Average Pain)
Number Analyzed Participants Participants Participants Participants
10.3(4.5 to 21.0) 17.6(8.0 to 30.7) 24.4(13.9 to 37.4) 8.6(3.2 to 19.3)
Week 2 (Average Pain)
Number Analyzed Participants Participants Participants Participants
17.9(9.8 to 30.0) 20.6(11.3 to 34.9) 36.6(24.6 to 50.0) 22.9(11.9 to 36.5)
Week 4 (Average Pain)
Number Analyzed Participants Participants Participants Participants
33.3(21.0 to 47.1) 20.6(11.3 to 34.9) 46.3(33.9 to 60.2) 34.3(22.0 to 47.8)
Week 6 (Average Pain)
Number Analyzed Participants Participants Participants Participants
48.7(35.6 to 61.9) 32.4(19.7 to 46.2) 48.8(35.1 to 62.6) 34.3(22.0 to 47.8)
Week 8 (Average Pain)
Number Analyzed Participants Participants Participants Participants
35.9(23.9 to 50.0) 26.5(15.9 to 40.5) 56.1(42.1 to 68.8) 29.4(16.9 to 43.3)
Week 12 (Average Pain)
Number Analyzed Participants Participants Participants Participants
41.0(27.7 to 55.4) 26.5(15.9 to 40.5) 41.5(28.4 to 55.5) 32.4(19.7 to 46.2)
Week 16 (Average Pain)
Number Analyzed Participants Participants Participants Participants
28.2(17.8 to 42.1) 20.6(11.3 to 34.9) 39.0(26.2 to 53.1) 32.4(19.7 to 46.2)
Week 1 (Pain at its Worst)
Number Analyzed Participants Participants Participants Participants
7.3(2.7 to 17.3) 18.9(10.4 to 31.8) 16.7(9.1 to 27.7) 19.5(10.1 to 31.2)
Week 2 (Pain at its Worst)
Number Analyzed Participants Participants Participants Participants
17.1(9.3 to 28.4) 21.6(11.2 to 34.3) 28.6(17.4 to 41.0) 24.4(13.9 to 37.4)
Week 4 (Pain at its Worst)
Number Analyzed Participants Participants Participants Participants
34.1(23.0 to 46.9) 16.2(7.3 to 29.3) 40.5(27.7 to 54.3) 31.7(19.9 to 44.5)
Week 6 (Pain at its Worst)
Number Analyzed Participants Participants Participants Participants
41.5(28.4 to 55.5) 21.6(11.2 to 34.3) 38.1(25.6 to 52.0) 29.3(17.8 to 42.1)
Week 8 (Pain at its Worst)
Number Analyzed Participants Participants Participants Participants
34.1(23.0 to 46.9) 29.7(18.5 to 43.3) 50.0(36.5 to 63.5) 27.5(17.5 to 40.9)
Week 12 (Pain at its Worst)
Number Analyzed Participants Participants Participants Participants
43.9(31.2 to 57.9) 29.7(18.5 to 43.3) 40.5(27.7 to 54.3) 35.0(23.4 to 48.3)
Week 16 (Pain at its Worst)
Number Analyzed Participants Participants Participants Participants
29.3(17.8 to 42.1) 21.6(11.2 to 34.3) 35.7(23.7 to 48.0) 35.0(23.4 to 48.3)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1687
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.7
Confidence Interval(2-sided) 90%
-5.7 to 21.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.20
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0376
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value13.8
Confidence Interval(2-sided) 90%
0.6 to 27.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.03
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5883
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.5
Confidence Interval(2-sided) 90%
-12.9 to 9.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.90
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3829
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value2.7
Confidence Interval(2-sided) 90%
-12.2 to 17.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.07
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0316
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value18.2
Confidence Interval(2-sided) 90%
2.5 to 33.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.54
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3072
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value4.6
Confidence Interval(2-sided) 90%
-10.5 to 19.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.17
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8952
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-13.1
Confidence Interval(2-sided) 90%
-29.8 to 3.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.18
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1157
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value13.1
Confidence Interval(2-sided) 90%
-4.6 to 30.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.76
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.4672
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.9
Confidence Interval(2-sided) 90%
-17.1 to 18.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.93
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.9287
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.9
Confidence Interval(2-sided) 90%
-35.5 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.29
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.4984
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.0
Confidence Interval(2-sided) 90%
-17.8 to 17.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.85
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.9001
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-14.7
Confidence Interval(2-sided) 90%
-33.2 to 3.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.27
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8319
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-10.3
Confidence Interval(2-sided) 90%
-27.6 to 7.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.53
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0340
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value19.7
Confidence Interval(2-sided) 90%
2.3 to 37.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.55
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7359
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.8
Confidence Interval(2-sided) 90%
-24.4 to 10.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.70
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.9291
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.0
Confidence Interval(2-sided) 90%
-33.3 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.51
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5087
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.2
Confidence Interval(2-sided) 90%
-17.4 to 16.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.44
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8098
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-9.5
Confidence Interval(2-sided) 90%
-27.2 to 8.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.74
Estimation Comments[Not specified]
Statistical Analysis 19
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8114
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.8
Confidence Interval(2-sided) 90%
-24.8 to 7.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.76
Estimation Comments[Not specified]
Statistical Analysis 20
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1531
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value10.8
Confidence Interval(2-sided) 90%
-6.4 to 28.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.44
Estimation Comments[Not specified]
Statistical Analysis 21
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16 (Average Pain)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3784
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value3.3
Confidence Interval(2-sided) 90%
-14.1 to 20.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.58
Estimation Comments[Not specified]
Statistical Analysis 22
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0559
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value12.1
Confidence Interval(2-sided) 90%
-0.7 to 24.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.75
Estimation Comments[Not specified]
Statistical Analysis 23
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0758
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value9.8
Confidence Interval(2-sided) 90%
-1.9 to 21.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.09
Estimation Comments[Not specified]
Statistical Analysis 24
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0637
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value11.3
Confidence Interval(2-sided) 90%
-0.6 to 23.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.21
Estimation Comments[Not specified]
Statistical Analysis 25
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3179
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value4.2
Confidence Interval(2-sided) 90%
-10.3 to 18.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.84
Estimation Comments[Not specified]
Statistical Analysis 26
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1078
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value11.0
Confidence Interval(2-sided) 90%
-3.5 to 25.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.82
Estimation Comments[Not specified]
Statistical Analysis 27
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1976
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.6
Confidence Interval(2-sided) 90%
-7.0 to 22.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.86
Estimation Comments[Not specified]
Statistical Analysis 28
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.9738
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-18.9
Confidence Interval(2-sided) 90%
-34.3 to -3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.32
Estimation Comments[Not specified]
Statistical Analysis 29
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2925
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value5.8
Confidence Interval(2-sided) 90%
-11.3 to 22.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.40
Estimation Comments[Not specified]
Statistical Analysis 30
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6178
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-3.1
Confidence Interval(2-sided) 90%
-19.8 to 13.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.18
Estimation Comments[Not specified]
Statistical Analysis 31
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.9769
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-20.9
Confidence Interval(2-sided) 90%
-37.4 to -4.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.04
Estimation Comments[Not specified]
Statistical Analysis 32
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6529
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.2
Confidence Interval(2-sided) 90%
-21.6 to 13.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.57
Estimation Comments[Not specified]
Statistical Analysis 33
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8878
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-12.8
Confidence Interval(2-sided) 90%
-29.8 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.36
Estimation Comments[Not specified]
Statistical Analysis 34
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7259
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.2
Confidence Interval(2-sided) 90%
-22.9 to 10.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.11
Estimation Comments[Not specified]
Statistical Analysis 35
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0826
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value14.8
Confidence Interval(2-sided) 90%
-2.1 to 31.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.24
Estimation Comments[Not specified]
Statistical Analysis 36
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7884
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.0
Confidence Interval(2-sided) 90%
-24.1 to 8.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.75
Estimation Comments[Not specified]
Statistical Analysis 37
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.9326
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-16.1
Confidence Interval(2-sided) 90%
-33.2 to 1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.43
Estimation Comments[Not specified]
Statistical Analysis 38
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6810
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.9
Confidence Interval(2-sided) 90%
-22.1 to 12.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.41
Estimation Comments[Not specified]
Statistical Analysis 39
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8308
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-10.3
Confidence Interval(2-sided) 90%
-27.6 to 7.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.52
Estimation Comments[Not specified]
Statistical Analysis 40
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8063
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.5
Confidence Interval(2-sided) 90%
-24.5 to 7.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.71
Estimation Comments[Not specified]
Statistical Analysis 41
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2649
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value6.5
Confidence Interval(2-sided) 90%
-10.4 to 23.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.27
Estimation Comments[Not specified]
Statistical Analysis 42
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16 (Pain at its Worst)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3029
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value5.3
Confidence Interval(2-sided) 90%
-11.7 to 22.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.35
Estimation Comments[Not specified]
9. Secondary Outcome:
Title Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst and on Average Respectively, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)
Description The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. The range of skin pain was from 0 to 10.
Time Frame At weeks 1, 2, 4, 6, 8, 12 and 16

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
Week 1-Average Pain
-2.47(-9.45 to 4.51) -8.64(-16.06 to -1.22) -13.53(-20.29 to -6.77) -8.81(-16.53 to -1.10)
Week 2-Average Pain
-11.24(-19.66 to -2.83) -13.39(-22.42 to -4.37) -21.59(-29.80 to -13.38) -13.49(-22.78 to -4.20)
Week 4-Average Pain
-24.04(-34.14 to -13.94) -16.00(-26.79 to -5.21) -33.01(-42.90 to -23.13) -18.67(-29.57 to -7.77)
Week 6-Average Pain
-28.65(-39.19 to -18.10) -14.86(-26.11 to -3.61) -38.04(-48.30 to -27.77) -22.60(-34.04 to -11.16)
Week 8-Average Pain
-30.75(-41.20 to -20.31) -21.78(-32.86 to -10.70) -39.59(-49.80 to -29.39) -22.11(-33.48 to -10.75)
Week 12-Average Pain
-30.85(-40.83 to -20.87) -28.50(-39.14 to -17.87) -45.24(-54.97 to -35.50) -30.42(-41.28 to -19.57)
Week 16-Average Pain
-27.83(-37.98 to -17.69) -23.80(-34.41 to -13.18) -46.21(-56.05 to -36.37) -31.92(-42.93 to -20.91)
Week 1-Pain at its Worst
-1.45(-9.33 to 6.42) -8.89(-17.18 to -0.61) -11.97(-19.58 to -4.37) -15.58(-23.50 to -7.66)
Week 2-Pain at its Worst
-7.49(-17.39 to 2.42) -13.15(-23.61 to -2.69) -19.40(-29.09 to -9.72) -19.19(-29.20 to -9.19)
Week 4-Pain at its Worst
-18.81(-29.31 to -8.31) -15.56(-26.68 to -4.45) -26.63(-36.88 to -16.37) -19.98(-30.63 to -9.33)
Week 6-Pain at its Worst
-21.80(-33.14 to -10.47) -13.86(-25.74 to -1.98) -32.89(-43.90 to -21.88) -21.76(-33.08 to -10.43)
Week 8-Pain at its Worst
-23.53(-34.49 to -12.57) -20.70(-32.22 to -9.18) -34.83(-45.55 to -24.11) -23.37(-34.40 to -12.35)
Week 12-Pain at its Worst
-26.04(-37.10 to -14.98) -25.38(-36.95 to -13.81) -41.35(-52.12 to -30.58) -32.43(-43.66 to -21.20)
Week 16-Pain at its Worst
-22.34(-33.82 to -10.86) -19.77(-31.60 to -7.93) -43.88(-55.06 to -32.70) -34.87(-46.36 to -23.38)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Unit of Measure appears inconsistent with the Measure Title, the Measure Description, or both.
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1505
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.17
Confidence Interval(2-sided) 90%
-15.98 to 3.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.963
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0233
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-11.06
Confidence Interval(2-sided) 90%
-20.19 to -1.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.555
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1423
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.34
Confidence Interval(2-sided) 90%
-16.09 to 3.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.926
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3827
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.15
Confidence Interval(2-sided) 90%
-14.00 to 9.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.202
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0624
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-10.35
Confidence Interval(2-sided) 90%
-21.44 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.741
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3771
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.25
Confidence Interval(2-sided) 90%
-14.04 to 9.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.171
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8247
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value8.04
Confidence Interval(2-sided) 90%
-6.13 to 22.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.614
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1337
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.97
Confidence Interval(2-sided) 90%
-22.28 to 4.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.090
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7357
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value5.37
Confidence Interval(2-sided) 90%
-8.65 to 19.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.523
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.9377
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value13.78
Confidence Interval(2-sided) 90%
-0.98 to 28.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.977
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1332
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-9.39
Confidence Interval(2-sided) 90%
-23.29 to 4.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.450
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7514
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value6.05
Confidence Interval(2-sided) 90%
-8.60 to 20.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.907
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8433
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value8.97
Confidence Interval(2-sided) 90%
-5.67 to 23.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.902
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1461
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-8.84
Confidence Interval(2-sided) 90%
-22.64 to 4.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.392
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8364
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value8.64
Confidence Interval(2-sided) 90%
-5.86 to 23.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.818
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6085
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value2.35
Confidence Interval(2-sided) 90%
-11.68 to 16.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.527
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0365
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-14.38
Confidence Interval(2-sided) 90%
-27.58 to -1.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.022
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5201
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.43
Confidence Interval(2-sided) 90%
-13.50 to 14.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.469
Estimation Comments[Not specified]
Statistical Analysis 19
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6813
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value4.04
Confidence Interval(2-sided) 90%
-10.05 to 18.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.564
Estimation Comments[Not specified]
Statistical Analysis 20
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0128
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-18.38
Confidence Interval(2-sided) 90%
-31.91 to -4.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.230
Estimation Comments[Not specified]
Statistical Analysis 21
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3181
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-4.09
Confidence Interval(2-sided) 90%
-18.30 to 10.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.639
Estimation Comments[Not specified]
Statistical Analysis 22
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1321
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-7.44
Confidence Interval(2-sided) 90%
-18.39 to 3.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.661
Estimation Comments[Not specified]
Statistical Analysis 23
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0477
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-10.52
Confidence Interval(2-sided) 90%
-20.90 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.308
Estimation Comments[Not specified]
Statistical Analysis 24
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0134
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-14.13
Confidence Interval(2-sided) 90%
-24.62 to -3.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.379
Estimation Comments[Not specified]
Statistical Analysis 25
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2496
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-5.66
Confidence Interval(2-sided) 90%
-19.45 to 8.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.380
Estimation Comments[Not specified]
Statistical Analysis 26
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0675
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-11.92
Confidence Interval(2-sided) 90%
-25.03 to 1.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.972
Estimation Comments[Not specified]
Statistical Analysis 27
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0730
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-11.71
Confidence Interval(2-sided) 90%
-24.96 to 1.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.054
Estimation Comments[Not specified]
Statistical Analysis 28
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6426
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value3.25
Confidence Interval(2-sided) 90%
-11.38 to 17.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.892
Estimation Comments[Not specified]
Statistical Analysis 29
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1776
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-7.82
Confidence Interval(2-sided) 90%
-21.73 to 6.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.457
Estimation Comments[Not specified]
Statistical Analysis 30
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.4458
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.17
Confidence Interval(2-sided) 90%
-15.28 to 12.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.579
Estimation Comments[Not specified]
Statistical Analysis 31
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7969
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.94
Confidence Interval(2-sided) 90%
-7.79 to 23.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.566
Estimation Comments[Not specified]
Statistical Analysis 32
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1120
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-11.09
Confidence Interval(2-sided) 90%
-26.09 to 3.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.120
Estimation Comments[Not specified]
Statistical Analysis 33
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5021
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.05
Confidence Interval(2-sided) 90%
-15.06 to 15.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.188
Estimation Comments[Not specified]
Statistical Analysis 34
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6197
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value2.83
Confidence Interval(2-sided) 90%
-12.46 to 18.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.296
Estimation Comments[Not specified]
Statistical Analysis 35
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1003
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-11.30
Confidence Interval(2-sided) 90%
-25.81 to 3.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.825
Estimation Comments[Not specified]
Statistical Analysis 36
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5070
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.16
Confidence Interval(2-sided) 90%
-14.50 to 14.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.908
Estimation Comments[Not specified]
Statistical Analysis 37
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5283
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.67
Confidence Interval(2-sided) 90%
-14.74 to 16.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.368
Estimation Comments[Not specified]
Statistical Analysis 38
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0431
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-15.31
Confidence Interval(2-sided) 90%
-29.98 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.921
Estimation Comments[Not specified]
Statistical Analysis 39
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2395
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-6.39
Confidence Interval(2-sided) 90%
-21.22 to 8.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.020
Estimation Comments[Not specified]
Statistical Analysis 40
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6054
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value2.57
Confidence Interval(2-sided) 90%
-13.25 to 18.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.617
Estimation Comments[Not specified]
Statistical Analysis 41
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0106
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-21.54
Confidence Interval(2-sided) 90%
-36.91 to -6.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.344
Estimation Comments[Not specified]
Statistical Analysis 42
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0890
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-12.54
Confidence Interval(2-sided) 90%
-27.84 to 2.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.305
Estimation Comments[Not specified]
10. Secondary Outcome:
Title Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale at Worst and on Average Respectively, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)
Description The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. The range of skin pain was from 0 to 10.
Time Frame At weeks 1, 2, 4, 6, 8, 12 and 16

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
Week 1-Average Pain
-0.19(-0.53 to 0.15) -0.44(-0.79 to -0.09) -0.62(-0.96 to -0.29) -0.50(-0.86 to -0.14)
Week 2-Average Pain
-0.49(-0.90 to -0.07) -0.77(-1.20 to -0.34) -0.94(-1.35 to -0.54) -0.66(-1.09 to -0.22)
Week 4-Average Pain
-1.22(-1.72 to -0.73) -1.10(-1.61 to -0.60) -1.73(-2.21 to -1.25) -1.02(-1.53 to -0.51)
Week 6-Average Pain
-1.49(-2.01 to -0.98) -0.98(-1.52 to -0.45) -1.92(-2.42 to -1.42) -1.29(-1.83 to -0.75)
Week 8-Average Pain
-1.56(-2.09 to -1.02) -1.35(-1.89 to -0.80) -1.88(-2.39 to -1.37) -1.30(-1.85 to -0.74)
Week 12-Average Pain
-1.68(-2.20 to -1.17) -1.71(-2.23 to -1.18) -2.25(-2.75 to -1.76) -1.53(-2.06 to -1.00)
Week 16-Average Pain
-1.40(-1.93 to -0.87) -1.37(-1.89 to -0.84) -2.29(-2.79 to -1.79) -1.77(-2.31 to -1.23)
Week 1-Pain at its Worst
-0.23(-0.59 to 0.13) -0.54(-0.91 to -0.16) -0.68(-1.03 to -0.33) -0.71(-1.09 to -0.33)
Week 2-Pain at its Worst
-0.52(-0.98 to -0.05) -0.84(-1.32 to -0.36) -1.07(-1.52 to -0.62) -0.91(-1.40 to -0.43)
Week 4-Pain at its Worst
-1.22(-1.74 to -0.70) -1.15(-1.68 to -0.61) -1.67(-2.17 to -1.16) -1.19(-1.74 to -0.65)
Week 6-Pain at its Worst
-1.55(-2.10 to -1.01) -1.06(-1.62 to -0.50) -1.97(-2.50 to -1.45) -1.43(-2.00 to -0.87)
Week 8-Pain at its Worst
-1.56(-2.11 to -1.01) -1.40(-1.97 to -0.83) -1.95(-2.48 to -1.41) -1.43(-2.01 to -0.86)
Week 12-Pain at its Worst
-1.80(-2.35 to -1.26) -1.74(-2.30 to -1.18) -2.37(-2.89 to -1.84) -1.80(-2.37 to -1.23)
Week 16-Pain at its Worst
-1.44(-2.00 to -0.89) -1.35(-1.91 to -0.80) -2.51(-3.04 to -1.98) -2.01(-2.58 to -1.44)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1898
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.25
Confidence Interval(2-sided) 90%
-0.72 to 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.284
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0562
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.43
Confidence Interval(2-sided) 90%
-0.88 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.273
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1382
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.31
Confidence Interval(2-sided) 90%
-0.78 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.284
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2039
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.28
Confidence Interval(2-sided) 90%
-0.85 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.343
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0855
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.45
Confidence Interval(2-sided) 90%
-1.00 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.332
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3089
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.17
Confidence Interval(2-sided) 90%
-0.74 to 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.344
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6124
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.12
Confidence Interval(2-sided) 90%
-0.55 to 0.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.407
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1003
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.50
Confidence Interval(2-sided) 90%
-1.15 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.395
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6875
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.20
Confidence Interval(2-sided) 90%
-0.47 to 0.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.408
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8833
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.51
Confidence Interval(2-sided) 90%
-0.19 to 1.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.427
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1502
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.43
Confidence Interval(2-sided) 90%
-1.11 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.413
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6788
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.20
Confidence Interval(2-sided) 90%
-0.50 to 0.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.428
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6835
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.21
Confidence Interval(2-sided) 90%
-0.51 to 0.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.441
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2237
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.32
Confidence Interval(2-sided) 90%
-1.02 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.425
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.7234
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.26
Confidence Interval(2-sided) 90%
-0.46 to 0.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.439
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.4773
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.02
Confidence Interval(2-sided) 90%
-0.72 to 0.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.424
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0818
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.57
Confidence Interval(2-sided) 90%
-1.25 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.410
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6397
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.15
Confidence Interval(2-sided) 90%
-0.55 to 0.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.424
Estimation Comments[Not specified]
Statistical Analysis 19
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5321
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.03
Confidence Interval(2-sided) 90%
-0.67 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.428
Estimation Comments[Not specified]
Statistical Analysis 20
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0167
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.89
Confidence Interval(2-sided) 90%
-1.59 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.420
Estimation Comments[Not specified]
Statistical Analysis 21
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16 Average Pain
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1963
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.37
Confidence Interval(2-sided) 90%
-1.09 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.434
Estimation Comments[Not specified]
Statistical Analysis 22
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1536
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.31
Confidence Interval(2-sided) 90%
-0.80 to 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.301
Estimation Comments[Not specified]
Statistical Analysis 23
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0581
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.45
Confidence Interval(2-sided) 90%
-0.93 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.289
Estimation Comments[Not specified]
Statistical Analysis 24
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0532
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.48
Confidence Interval(2-sided) 90%
-0.98 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.300
Estimation Comments[Not specified]
Statistical Analysis 25
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2007
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.32
Confidence Interval(2-sided) 90%
-0.95 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.383
Estimation Comments[Not specified]
Statistical Analysis 26
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0694
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.55
Confidence Interval(2-sided) 90%
-1.16 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.370
Estimation Comments[Not specified]
Statistical Analysis 27
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1509
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.39
Confidence Interval(2-sided) 90%
-1.02 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.382
Estimation Comments[Not specified]
Statistical Analysis 28
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5663
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.07
Confidence Interval(2-sided) 90%
-0.64 to 0.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.431
Estimation Comments[Not specified]
Statistical Analysis 29
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1396
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.45
Confidence Interval(2-sided) 90%
-1.13 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.416
Estimation Comments[Not specified]
Statistical Analysis 30
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5227
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.02
Confidence Interval(2-sided) 90%
-0.69 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.432
Estimation Comments[Not specified]
Statistical Analysis 31
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.8656
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.50
Confidence Interval(2-sided) 90%
-0.24 to 1.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.450
Estimation Comments[Not specified]
Statistical Analysis 32
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1671
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.42
Confidence Interval(2-sided) 90%
-1.13 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.434
Estimation Comments[Not specified]
Statistical Analysis 33
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6063
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.12
Confidence Interval(2-sided) 90%
-0.62 to 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.450
Estimation Comments[Not specified]
Statistical Analysis 34
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6402
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.16
Confidence Interval(2-sided) 90%
-0.59 to 0.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.458
Estimation Comments[Not specified]
Statistical Analysis 35
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1916
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.38
Confidence Interval(2-sided) 90%
-1.11 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.441
Estimation Comments[Not specified]
Statistical Analysis 36
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.6119
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.13
Confidence Interval(2-sided) 90%
-0.62 to 0.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.456
Estimation Comments[Not specified]
Statistical Analysis 37
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5568
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.06
Confidence Interval(2-sided) 90%
-0.68 to 0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.450
Estimation Comments[Not specified]
Statistical Analysis 38
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0976
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.56
Confidence Interval(2-sided) 90%
-1.27 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.433
Estimation Comments[Not specified]
Statistical Analysis 39
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5001
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.00
Confidence Interval(2-sided) 90%
-0.74 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.451
Estimation Comments[Not specified]
Statistical Analysis 40
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.5810
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value0.09
Confidence Interval(2-sided) 90%
-0.65 to 0.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.451
Estimation Comments[Not specified]
Statistical Analysis 41
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0079
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-1.07
Confidence Interval(2-sided) 90%
-1.80 to -0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.442
Estimation Comments[Not specified]
Statistical Analysis 42
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16 Pain at its Worst
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1068
CommentsOne-sided p-value
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-0.57
Confidence Interval(2-sided) 90%
-1.31 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.455
Estimation Comments[Not specified]
11. Secondary Outcome:
Title Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI)
Description Erythema response was defined as achieving erythema score of 1 or 0 in all affected anatomic regions among participants who had an erythema score of 2 or more in at least 1 anatomic region at baseline. NRI for missing values which were related to withdrawal and all other events except for COVID-19. A four-point ordinal scale ranging was used: 0 (no redness), 1 (faint but discernible pink coloration), 2 (moderate red coloration), and 3 (very red or bright red coloration).
Time Frame At weeks 1, 2, 4, 6, 8, 12 and 16
Outcome Measure Data
Analysis Population Description
All participants randomized and received at least one dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 1
Number Analyzed Participants Participants Participants Participants
6.5(2.4 to 15.8) 4.7(1.2 to 13.2) 8.7(3.8 to 17.6) 13.6(6.1 to 24.3)
Week 2
Number Analyzed Participants Participants Participants Participants
10.9(5.4 to 21.3) 20.9(12.3 to 33.3) 17.8(9.2 to 29.7) 18.2(9.4 to 30.0)
Week 4
Number Analyzed Participants Participants Participants Participants
13.3(6.0 to 23.7) 20.9(12.3 to 33.3) 28.3(17.6 to 40.4) 18.2(9.4 to 30.0)
Week 6
Number Analyzed Participants Participants Participants Participants
13.0(5.8 to 23.2) 27.9(17.0 to 39.9) 23.9(15.1 to 35.0) 23.3(13.2 to 35.5)
Week 8
Number Analyzed Participants Participants Participants Participants
15.2(8.2 to 25.5) 25.6(16.3 to 37.7) 28.3(17.6 to 40.4) 23.3(13.2 to 35.5)
Week 12
Number Analyzed Participants Participants Participants Participants
15.2(8.2 to 25.5) 23.3(13.2 to 35.5) 30.4(20.4 to 43.4) 18.6(9.6 to 30.2)
Week 16
Number Analyzed Participants Participants Participants Participants
13.0(5.8 to 23.2) 16.3(8.8 to 27.0) 28.3(17.6 to 40.4) 18.6(9.6 to 30.2)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value-2.2
Confidence Interval(2-sided) 90%
-10.3 to 6.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.98
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value2.0
Confidence Interval(2-sided) 90%
-7.3 to 11.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.64
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 1
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value6.8
Confidence Interval(2-sided) 90%
-3.9 to 17.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.47
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value10.7
Confidence Interval(2-sided) 90%
-2.0 to 23.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.74
Estimation Comments[Not specified]
Statistical Analysis 5
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.6
Confidence Interval(2-sided) 90%
-4.5 to 19.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.34
Estimation Comments[Not specified]
Statistical Analysis 6
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 2
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.5
Confidence Interval(2-sided) 90%
-4.6 to 19.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.36
Estimation Comments[Not specified]
Statistical Analysis 7
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.4
Confidence Interval(2-sided) 90%
-5.7 to 20.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.95
Estimation Comments[Not specified]
Statistical Analysis 8
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value15.1
Confidence Interval(2-sided) 90%
1.4 to 28.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.33
Estimation Comments[Not specified]
Statistical Analysis 9
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 4
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value4.8
Confidence Interval(2-sided) 90%
-8.0 to 17.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.74
Estimation Comments[Not specified]
Statistical Analysis 10
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value14.3
Confidence Interval(2-sided) 90%
0.7 to 28.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.30
Estimation Comments[Not specified]
Statistical Analysis 11
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value10.9
Confidence Interval(2-sided) 90%
-2.2 to 24.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.96
Estimation Comments[Not specified]
Statistical Analysis 12
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 6
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value10.6
Confidence Interval(2-sided) 90%
-2.6 to 23.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.06
Estimation Comments[Not specified]
Statistical Analysis 13
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1162
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value10.1
Confidence Interval(2-sided) 90%
-3.6 to 23.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.38
Estimation Comments[Not specified]
Statistical Analysis 14
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0642
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value13.1
Confidence Interval(2-sided) 90%
-0.8 to 27.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.43
Estimation Comments[Not specified]
Statistical Analysis 15
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 8
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1664
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value8.1
Confidence Interval(2-sided) 90%
-5.7 to 21.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.36
Estimation Comments[Not specified]
Statistical Analysis 16
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1882
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value7.2
Confidence Interval(2-sided) 90%
-6.1 to 20.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.10
Estimation Comments[Not specified]
Statistical Analysis 17
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0423
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value14.9
Confidence Interval(2-sided) 90%
1.1 to 28.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.43
Estimation Comments[Not specified]
Statistical Analysis 18
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 12
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3396
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value3.3
Confidence Interval(2-sided) 90%
-9.7 to 16.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.90
Estimation Comments[Not specified]
Statistical Analysis 19
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06650833 400mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3584
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value2.7
Confidence Interval(2-sided) 90%
-9.4 to 14.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.35
Estimation Comments[Not specified]
Statistical Analysis 20
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06700841 45mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0367
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value14.9
Confidence Interval(2-sided) 90%
1.5 to 28.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.17
Estimation Comments[Not specified]
Statistical Analysis 21
Statistical Analysis OverviewComparison Group SelectionPlacebo, PF-06826647 400mg QD
CommentsWeek 16
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2486
CommentsOne-sided p-value
MethodMR weighting strategy
CommentsP-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value5.2
Confidence Interval(2-sided) 90%
-7.4 to 17.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.65
Estimation Comments[Not specified]
12. Secondary Outcome:
Title Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
Description The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Time Frame From the first dose of study intervention up to week 16
Outcome Measure Data
Analysis Population Description
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with adverse events
23
47.9%
26
55.3%
30
57.7%
29
61.7%
Participants with serious adverse events
0
0%
2
4.3%
0
0%
2
4.3%
Participants with severe adverse events
1
2.1%
2
4.3%
1
1.9%
4
8.5%
Participants discontinued from study due to adverse events
0
0%
1
2.1%
1
1.9%
6
12.8%
Participants discontinued study drug due to AE and continued Study
1
2.1%
2
4.3%
2
3.8%
1
2.1%
Participants with temporary discontinuation due to adverse events
2
4.2%
1
2.1%
3
5.8%
5
10.6%
13. Secondary Outcome:
Title Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
Description The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Time Frame From the first dose of study intervention up to week 16
Outcome Measure Data
Analysis Population Description
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with adverse events
7
14.6%
10
21.3%
12
23.1%
16
34%
Participants with serious adverse events
0
0%
1
2.1%
0
0%
1
2.1%
Participants with severe adverse events
0
0%
1
2.1%
0
0%
3
6.4%
Participants discontinued from study due to adverse events
0
0%
1
2.1%
1
1.9%
4
8.5%
Participants discontinued study drug due to AE and continued Study
1
2.1%
1
2.1%
2
3.8%
0
0%
Participants with temporary discontinuation due to adverse events
1
2.1%
1
2.1%
0
0%
2
4.3%
14. Secondary Outcome:
Title Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)
Description The vital signs were measured included temperature (Oral, Tympanic, Axillary or Temporal), pulse rate (beats/min) and blood pressure (mmHg).
Time Frame From the first dose of study intervention up to week 16
Outcome Measure Data
Analysis Population Description
All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Measure Type: Count of Participants
Unit of Measure: Participants
Supine Diastolic Blood Pressure (MMHG): Change >= 20mmHg increase
2
4.2%
1
2.1%
2
3.8%
4
8.5%
Supine Systolic Blood Pressure (MMHG): Change >= 30mmHg increase
1
2.1%
1
2.1%
2
3.8%
4
8.5%
15. Secondary Outcome:
Title Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)
Description Laboratory test abnormalities included hematology, chemistry, urinalysis and biomarker.
Time Frame From the first dose of study intervention up to week 16
Outcome Measure Data
Analysis Population Description
All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
   
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed48 47 52 47
Measure Type: Count of Participants
Unit of Measure: Participants
 
Hematology: hemoglobin (g/dL) <0.8x lower limit of normal (LLN)
Number Analyzed Participants Participants Participants Participants
1
2.1%
0
0%
4
7.7%
0
0%
Hematology: Hematocrit (%) <0.8x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
1
1.9%
0
0%
Hematology: Erythrocytes (10^6/mm^3) <0.8x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
3
5.8%
1
2.1%
Hematology: Ery. Mean Corpuscular Volume (um^3) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
1
2.1%
2
4.3%
1
1.9%
0
0%
Hematology: Ery. Mean Corpuscular Volume (um^3) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
2
4.3%
1
1.9%
1
2.1%
Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
5
10.4%
5
10.6%
7
13.5%
5
10.6%
Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
6
12.5%
3
6.4%
6
11.5%
6
12.8%
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Hematology: Mean Platelet Volume (fL) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
2
4.3%
Hematology: Mean Platelet Volume (fL) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
1
2.1%
0
0%
0
0%
0
0%
Hematology: Platelets (10^3/mm^3) <0.5x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
1
2.1%
Hematology: Platelets (10^3/mm^3) >1.75x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
1
1.9%
3
6.4%
Hematology: Leukocytes (10^3/mm^3) <0.6x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
1
1.9%
3
6.4%
Hematology: Leukocytes (10^3/mm^3) >1.5x ULN
Number Analyzed Participants Participants Participants Participants
4
8.3%
1
2.1%
1
1.9%
0
0%
Hematology: Lymphocytes (10^3/mm^3) <0.8x LLN
Number Analyzed Participants Participants Participants Participants
1
2.1%
0
0%
1
1.9%
3
6.4%
Hematology: Lymphocytes (10^3/mm^3) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
5
10.4%
2
4.3%
7
13.5%
4
8.5%
Hematology: Neutrophils (10^3/mm^3) <0.8x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
3
5.8%
8
17%
Hematology: Neutrophils (10^3/mm^3) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
8
16.7%
3
6.4%
6
11.5%
4
8.5%
Hematology: Basophils (10^3/mm^3) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Hematology: Eosinophils (10^3/mm^3) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
1
2.1%
0
0%
0
0%
Hematology: Monocytes (10^3/mm^3) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
2
4.2%
0
0%
0
0%
0
0%
Clinical Chemistry: Bilirubin (mg/dL) >1.5x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Aspartate Aminotransferase (U/L) >3.0x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
1
2.1%
1
1.9%
0
0%
Clinical Chemistry: Alanine Aminotransferase (U/L) >3.0x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
1
2.1%
2
3.8%
1
2.1%
Clinical Chemistry: Alkaline Phosphatase (U/L) >3.0x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Protein (g/dL) <0.8x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Protein (g/dL) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Albumin (g/dL) <0.8x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Albumin (g/dL) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Urea Nitrogen (mg/dL) >1.3x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
1
2.1%
0
0%
2
4.3%
Clinical Chemistry: Creatinine (mg/dL) >1.3x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
1
1.9%
0
0%
Clinical Chemistry: Urate (mg/dL) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
3
6.2%
3
6.4%
4
7.7%
6
12.8%
Clinical Chemistry: Cholesterol (mg/dL) >1.3x ULN
Number Analyzed Participants Participants Participants Participants
2
4.2%
1
2.1%
4
7.7%
2
4.3%
Clinical Chemistry: HDL Cholesterol (mg/dL) <0.8x LLN
Number Analyzed Participants Participants Participants Participants
10
20.8%
6
12.8%
6
11.5%
5
10.6%
Clinical Chemistry: LDL Cholesterol (mg/dL) >1.2x ULN
Number Analyzed Participants Participants Participants Participants
1
2.1%
1
2.1%
3
5.8%
2
4.3%
Clinical Chemistry: Triglycerides (mg/dL) >1.3x ULN
Number Analyzed Participants Participants Participants Participants
5
10.4%
4
8.5%
6
11.5%
7
14.9%
Clinical Chemistry: Sodium (mEq/L) <0.95x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Sodium (mEq/L) >1.05x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Potassium (mEq/L) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
1
2.1%
1
2.1%
1
1.9%
0
0%
Clinical Chemistry: Potassium (mEq/L) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
1
2.1%
2
4.3%
0
0%
2
4.3%
Clinical Chemistry: Chloride (mEq/L) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Chloride (mEq/L) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Calcium (mg/dL) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
2
4.3%
0
0%
0
0%
Clinical Chemistry: Calcium (mg/dL) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Bicarbonate (mEq/L) <0.9x LLN
Number Analyzed Participants Participants Participants Participants
10
20.8%
10
21.3%
2
3.8%
13
27.7%
Clinical Chemistry: Bicarbonate (mEq/L) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
0
0%
1
2.1%
0
0%
0
0%
Clinical Chemistry: Glucose (mg/dL) <0.6x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Glucose (mg/dL) >1.5x ULN
Number Analyzed Participants Participants Participants Participants
1
2.1%
2
4.3%
1
1.9%
3
6.4%
Clinical Chemistry: Creatine Kinase (U/L) >2.0x ULN
Number Analyzed Participants Participants Participants Participants
6
12.5%
2
4.3%
18
34.6%
20
42.6%
Clinical Chemistry: Glucose -FASTING (mg/dL) <0.6x LLN
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Clinical Chemistry: Glucose -FASTING (mg/dL) >1.5x ULN
Number Analyzed Participants Participants Participants Participants
4
8.3%
5
10.6%
3
5.8%
5
10.6%
Urinalysis: pH <4.5
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Urinalysis: pH >8
Number Analyzed Participants Participants Participants Participants
2
4.2%
1
2.1%
2
3.8%
5
10.6%
Urinalysis: URINE Glucose (mg/dL) ≥1
Number Analyzed Participants Participants Participants Participants
4
8.3%
6
12.8%
2
3.8%
4
8.5%
Urinalysis: Ketones (mg/dL) ≥1
Number Analyzed Participants Participants Participants Participants
9
18.8%
6
12.8%
8
15.4%
12
25.5%
Urinalysis: URINE Protein (mg/dL) ≥1
Number Analyzed Participants Participants Participants Participants
32
66.7%
30
63.8%
29
55.8%
32
68.1%
Urinalysis: URINE Hemoglobin ≥1
Number Analyzed Participants Participants Participants Participants
23
47.9%
9
19.1%
16
30.8%
10
21.3%
Urinalysis: Urobilinogen (EU/dL) ≥1
Number Analyzed Participants Participants Participants Participants
3
6.2%
4
8.5%
7
13.5%
5
10.6%
Urinalysis: URINE Bilirubin ≥1
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Urinalysis: Nitrite ≥1
Number Analyzed Participants Participants Participants Participants
3
6.2%
4
8.5%
6
11.5%
3
6.4%
Urinalysis: Leukocyte Esterase ≥1
Number Analyzed Participants Participants Participants Participants
10
20.8%
5
10.6%
9
17.3%
6
12.8%
Urinalysis: URINE Erythrocytes (/HPF) ≥20
Number Analyzed Participants Participants Participants Participants
4
8.3%
2
4.3%
5
9.6%
1
2.1%
Urinalysis: Granular Casts (/LPF) >1
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Urinalysis: Hyaline Casts (/LPF) >1
Number Analyzed Participants Participants Participants Participants
1
2.1%
1
2.1%
1
1.9%
2
4.3%
Urinalysis: RBC Casts (/LPF) >1
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Urinalysis: WBC Casts (/LPF) >1
Number Analyzed Participants Participants Participants Participants
0
0%
0
0%
0
0%
0
0%
Urinalysis: Bacteria (/HPF) >20
Number Analyzed Participants Participants Participants Participants
6
12.5%
6
12.8%
5
9.6%
4
8.5%
Biomarker: C Reactive Protein (mg/dL) >1.1x ULN
Number Analyzed Participants Participants Participants Participants
37
77.1%
29
61.7%
37
71.2%
30
63.8%
16. Secondary Outcome:
Title Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)
Description ECG parameters included QT interval, QTc interval, PR interval, and QRS complex.
Time Frame From the first dose of study intervention up to week 16
Outcome Measure Data
Analysis Population Description
All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
 
Arm/Group TitlePlaceboPF-06650833 400mg QDPF-06700841 45mg QDPF-06826647 400mg QD
Arm/Group DescriptionParticipants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647.PF-06650833 400mg was administered orally once daily (QD) by tablet.PF-06700841 45mg was administered orally once daily (QD) by tablet.PF-06826647 400mg was administered orally once daily (QD) by tablet.
Overall Number of Participants Analyzed47 45 50 45
Measure Type: Count of Participants
Unit of Measure: Participants
PR INTERVAL, SINGLE BEAT (MSEC): Value>280
0
0%
0
0%
0
0%
0
0%
QRS DURATION, SINGLE BEAT (MSEC): Value>120
2
4.3%
0
0%
3
6%
1
2.2%
QT INTERVAL, SINGLE BEAT (MSEC): Value>500
0
0%
0
0%
0
0%
0
0%
QTCB INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480
12
25.5%
12
26.7%
16
32%
7
15.6%
QTCB INTERVAL, SINGLE BEAT (MSEC): 480<Value<500
1
2.1%
0
0%
2
4%
1
2.2%
QTCB INTERVAL, SINGLE BEAT (MSEC): Value>=500
1
2.1%
0
0%
1
2%
0
0%
QTCB INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60
9
19.1%
12
26.7%
<