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Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

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ClinicalTrials.gov Identifier: NCT02969044
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Placebo
Drug: PF-06651600
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description Participants received 200 milligram (mg) of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug. Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Period Title: Overall Study
Started 42 28
Completed 37 22
Not Completed 5 6
Reason Not Completed
Withdrawal by Subject             2             6
Adverse Event             3             0
Arm/Group Title PF-06651600 Placebo Total
Hide Arm/Group Description Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug. Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug. Total of all reporting groups
Overall Number of Baseline Participants 42 28 70
Hide Baseline Analysis Population Description
Intent to treat (ITT) analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 28 participants 70 participants
55.4  (11.72) 54.2  (11.78) 54.9  (11.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 28 participants 70 participants
Female
33
  78.6%
24
  85.7%
57
  81.4%
Male
9
  21.4%
4
  14.3%
13
  18.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 28 participants 70 participants
Hispanic or Latino
1
   2.4%
2
   7.1%
3
   4.3%
Not Hispanic or Latino
41
  97.6%
26
  92.9%
67
  95.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 28 participants 70 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.4%
0
   0.0%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
41
  97.6%
28
 100.0%
69
  98.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
Hide Description The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (<=) 3.3 indicates disease remission, greater than (>) 3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 42 participants 28 participants
45.15  (13.164) 44.85  (13.976)
Change at Week 8 Number Analyzed 39 participants 24 participants
-26.11  (14.834) -17.38  (18.176)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06651600, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.25
Confidence Interval (2-Sided) 95%
-14.75 to -3.79
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Vital Signs Abnormalities
Hide Description Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Count of Participants
Unit of Measure: Participants
Sitting DBP >=20 mmHg increase from baseline
3
   7.1%
0
   0.0%
Sitting DBP >=20 mmHg decrease from baseline
0
   0.0%
1
   3.6%
3.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Count of Participants
Unit of Measure: Participants
42 28
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
20
  47.6%
5
  17.9%
SAEs
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6
Hide Description The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame Baseline, Week 1, 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 1 Number Analyzed 40 participants 28 participants
-4.59  (9.409) -4.52  (7.025)
Change at Week 2 Number Analyzed 42 participants 27 participants
-12.82  (10.969) -8.05  (9.402)
Change at Week 4 Number Analyzed 41 participants 26 participants
-17.79  (12.804) -12.55  (13.462)
Change at Week 6 Number Analyzed 40 participants 26 participants
-22.79  (14.007) -15.62  (14.231)
6.Secondary Outcome
Title Remission Rate Based on Simple Disease Activity Index Score
Hide Description Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame Week 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 4.8 0.0
Week 6 4.8 0.0
Week 8 7.1 0.0
7.Secondary Outcome
Title Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
Hide Description Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Time Frame Week 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 4.8 0.0
Week 6 2.4 0.0
Week 8 7.1 0.0
8.Secondary Outcome
Title Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
Hide Description Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame Week 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 4.8 0.0
Week 6 4.8 0.0
Week 8 7.1 0.0
9.Secondary Outcome
Title Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
Hide Description Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame Week 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 9.5 0.0
Week 6 7.1 3.6
Week 8 9.5 0.0
10.Secondary Outcome
Title Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
Hide Description Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
Time Frame Week 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 9.5 0.0
Week 6 9.5 3.6
Week 8 9.5 0.0
11.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8
Hide Description DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 42 participants 28 participants
6.49  (0.762) 6.37  (0.815)
Change at Week 1 Number Analyzed 40 participants 28 participants
-0.19  (0.604) -0.26  (0.434)
Change at Week 2 Number Analyzed 42 participants 27 participants
-0.67  (0.602) -0.46  (0.531)
Change at Week 4 Number Analyzed 41 participants 26 participants
-1.16  (1.125) -0.78  (0.905)
Change at Week 6 Number Analyzed 40 participants 25 participants
-1.54  (1.123) -1.07  (0.989)
Change at Week 8 Number Analyzed 39 participants 24 participants
-1.85  (1.161) -1.07  (1.214)
12.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8
Hide Description DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 42 participants 28 participants
6.82  (0.815) 6.72  (0.880)
Change at Week 1 Number Analyzed 40 participants 28 participants
-0.27  (0.553) -0.27  (0.477)
Change at Week 2 Number Analyzed 42 participants 27 participants
-0.83  (0.695) -0.47  (0.551)
Change at Week 4 Number Analyzed 41 participants 26 participants
-1.36  (1.173) -0.89  (0.951)
Change at Week 6 Number Analyzed 40 participants 25 participants
-1.81  (1.179) -1.18  (1.050)
Change at Week 8 Number Analyzed 39 participants 24 participants
-2.14  (1.269) -1.22  (1.448)
13.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8
Hide Description DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 42 participants 28 participants
5.76  (0.824) 5.61  (0.894)
Change at Week 1 Number Analyzed 40 participants 28 participants
-0.35  (0.741) -0.20  (0.456)
Change at Week 2 Number Analyzed 42 participants 27 participants
-0.86  (0.782) -0.47  (0.585)
Change at Week 4 Number Analyzed 41 participants 26 participants
-1.33  (1.219) -0.72  (1.005)
Change at Week 6 Number Analyzed 40 participants 26 participants
-1.53  (1.286) -1.01  (0.993)
Change at Week 8 Number Analyzed 39 participants 24 participants
-1.79  (1.265) -1.03  (1.146)
14.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8
Hide Description DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 42 participants 28 participants
6.11  (0.850) 5.98  (0.926)
Change at Week 1 Number Analyzed 40 participants 28 participants
-0.41  (0.685) -0.21  (0.473)
Change at Week 2 Number Analyzed 42 participants 27 participants
-0.99  (0.823) -0.47  (0.574)
Change at Week 4 Number Analyzed 41 participants 26 participants
-1.49  (1.222) -0.82  (1.013)
Change at Week 6 Number Analyzed 40 participants 26 participants
-1.78  (1.304) -1.09  (1.057)
Change at Week 8 Number Analyzed 39 participants 24 participants
-2.06  (1.321) -1.16  (1.367)
15.Secondary Outcome
Title Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8
Hide Description [Not Specified]
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter
Baseline Number Analyzed 42 participants 28 participants
2.00  (1.816) 1.68  (2.853)
Change at Week 1 Number Analyzed 40 participants 28 participants
-0.20  (2.672) 0.60  (2.263)
Change at Week 2 Number Analyzed 42 participants 27 participants
-0.62  (2.090) -0.04  (0.966)
Change at Week 4 Number Analyzed 41 participants 26 participants
-0.93  (1.591) 0.00  (1.335)
Change at Week 6 Number Analyzed 40 participants 26 participants
-0.42  (2.376) -0.23  (1.327)
Change at Week 8 Number Analyzed 39 participants 24 participants
-0.89  (2.142) -0.04  (2.220)
16.Secondary Outcome
Title Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8
Hide Description Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: joint count
Baseline: Tender joint count Number Analyzed 42 participants 28 participants
16.74  (6.765) 16.75  (6.681)
Baseline: Swollen joint count Number Analyzed 42 participants 28 participants
12.95  (5.396) 12.11  (6.160)
Change at Week 1: Tender joint count Number Analyzed 41 participants 28 participants
-1.54  (4.915) -1.96  (2.701)
Change at Week 1: Swollen joint count Number Analyzed 41 participants 28 participants
-1.49  (4.439) -2.46  (3.501)
Change at Week 2: Tender joint count Number Analyzed 42 participants 27 participants
-4.40  (5.522) -2.56  (5.213)
Change at Week 2: Swollen joint count Number Analyzed 42 participants 27 participants
-4.71  (4.430) -4.11  (4.619)
Change at Week 4: Tender joint count Number Analyzed 41 participants 26 participants
-6.76  (6.818) -4.96  (7.750)
Change at Week 4: Swollen joint count Number Analyzed 41 participants 26 participants
-5.95  (4.950) -4.85  (4.961)
Change at Week 6: Tender joint count Number Analyzed 40 participants 26 participants
-8.75  (7.132) -6.42  (6.652)
Change at Week 6: Swollen joint count Number Analyzed 40 participants 26 participants
-7.80  (5.743) -5.85  (5.540)
Change at Week 8: Tender joint count Number Analyzed 39 participants 24 participants
-10.21  (7.259) -6.83  (7.755)
Change at Week 8: Swollen joint count Number Analyzed 39 participants 24 participants
-8.59  (6.176) -6.54  (6.324)
17.Secondary Outcome
Title Change From Baseline in Participant’s Assessment of Arthritis Pain (PAAP), Participant’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8
Hide Description PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician’s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: PAAP Number Analyzed 42 participants 28 participants
66.64  (16.771) 71.75  (16.183)
Baseline: PGA Number Analyzed 42 participants 28 participants
68.43  (15.639) 69.00  (16.115)
Baseline: PGAA Number Analyzed 42 participants 28 participants
66.17  (14.228) 74.07  (12.844)
Change at Week 1: PAAP Number Analyzed 41 participants 28 participants
-4.95  (11.388) -2.86  (14.847)
Change at Week 1: PGA Number Analyzed 41 participants 28 participants
-6.76  (11.128) -1.93  (9.149)
Change at Week 1: PGAA Number Analyzed 41 participants 28 participants
-6.83  (8.947) -4.96  (8.126)
Change at Week 2: PAAP Number Analyzed 42 participants 27 participants
-11.90  (18.061) -6.04  (12.669)
Change at Week 2: PGA Number Analyzed 42 participants 27 participants
-14.74  (15.963) -2.81  (9.931)
Change at Week 2: PGAA Number Analyzed 42 participants 27 participants
-16.07  (16.499) -10.63  (12.500)
Change at Week 4: PAAP Number Analyzed 41 participants 26 participants
-19.88  (16.695) -10.23  (25.513)
Change at Week 4: PGA Number Analyzed 41 participants 26 participants
-20.05  (13.746) -12.12  (19.574)
Change at Week 4: PGAA Number Analyzed 41 participants 26 participants
-21.49  (16.715) -17.96  (18.877)
Change at Week 6: PAAP Number Analyzed 40 participants 26 participants
-27.90  (20.061) -12.35  (27.425)
Change at Week 6: PGA Number Analyzed 40 participants 26 participants
-27.83  (18.936) -11.65  (21.630)
Change at Week 6: PGAA Number Analyzed 40 participants 26 participants
-30.45  (17.868) -19.50  (22.963)
Change at Week 8: PAAP Number Analyzed 39 participants 24 participants
-32.92  (25.051) -18.58  (34.152)
Change at Week 8: PGA Number Analyzed 39 participants 24 participants
-30.92  (21.279) -15.88  (30.135)
Change at Week 8: PGAA Number Analyzed 39 participants 24 participants
-33.28  (18.725) -23.75  (25.902)
18.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8
Hide Description HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Time Frame Baseline, Week 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description:
Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Overall Number of Participants Analyzed 42 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 42 participants 28 participants
1.79  (0.577) 1.69  (0.550)
Change at Week 1 Number Analyzed 41 participants 28 participants
-0.13  (0.391) -0.04  (0.316)
Change at Week 2 Number Analyzed 42 participants 27 participants
-0.26  (0.430) -0.15  (0.347)
Change at Week 4 Number Analyzed 41 participants 26 participants
-0.39  (0.414) -0.19  (0.534)
Change at Week 6 Number Analyzed 40 participants 26 participants
-0.46  (0.527) -0.23  (0.609)
Change at Week 8 Number Analyzed 39 participants 24 participants
-0.53  (0.583) -0.32  (0.671)
Time Frame Baseline up to Week 12
Adverse Event Reporting Description Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
 
Arm/Group Title PF-06651600 Placebo
Hide Arm/Group Description Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug. Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
All-Cause Mortality
PF-06651600 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
PF-06651600 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-06651600 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   20/42 (47.62%)   5/28 (17.86%) 
Blood and lymphatic system disorders     
Lymphopenia * 1  3/42 (7.14%)  0/28 (0.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/42 (2.38%)  0/28 (0.00%) 
Glossitis * 1  1/42 (2.38%)  0/28 (0.00%) 
Nausea * 1  1/42 (2.38%)  0/28 (0.00%) 
Vomiting * 1  1/42 (2.38%)  0/28 (0.00%) 
General disorders     
Fatigue * 1  1/42 (2.38%)  0/28 (0.00%) 
Oedema peripheral * 1  1/42 (2.38%)  0/28 (0.00%) 
Hepatobiliary disorders     
Hepatotoxicity * 1  1/42 (2.38%)  0/28 (0.00%) 
Infections and infestations     
Asymptomatic bacteriuria * 1  1/42 (2.38%)  0/28 (0.00%) 
Fungal skin infection * 1  1/42 (2.38%)  0/28 (0.00%) 
Influenza * 1  3/42 (7.14%)  0/28 (0.00%) 
Oral herpes * 1  1/42 (2.38%)  0/28 (0.00%) 
Upper respiratory tract infection * 1  0/42 (0.00%)  1/28 (3.57%) 
Injury, poisoning and procedural complications     
Fall * 1  1/42 (2.38%)  0/28 (0.00%) 
Ligament sprain * 1  1/42 (2.38%)  0/28 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  0/42 (0.00%)  1/28 (3.57%) 
Aspartate aminotransferase increased * 1  0/42 (0.00%)  1/28 (3.57%) 
Blood creatine phosphokinase increased * 1  1/42 (2.38%)  0/28 (0.00%) 
Cytomegalovirus test positive * 1  1/42 (2.38%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/42 (2.38%)  0/28 (0.00%) 
Spinal pain * 1  0/42 (0.00%)  1/28 (3.57%) 
Synovitis * 1  1/42 (2.38%)  0/28 (0.00%) 
Nervous system disorders     
Headache * 1  0/42 (0.00%)  3/28 (10.71%) 
Psychiatric disorders     
Suicidal ideation * 1  1/42 (2.38%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  1/42 (2.38%)  0/28 (0.00%) 
Dermatitis * 1  1/42 (2.38%)  0/28 (0.00%) 
Pruritus * 1  2/42 (4.76%)  1/28 (3.57%) 
Rash maculo-papular * 1  1/42 (2.38%)  0/28 (0.00%) 
1
Term from vocabulary, MedDRA v20.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02969044     History of Changes
Other Study ID Numbers: B7981006
2016-002862-30 ( EudraCT Number )
First Submitted: November 17, 2016
First Posted: November 21, 2016
Results First Submitted: November 6, 2018
Results First Posted: December 4, 2018
Last Update Posted: December 4, 2018