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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis (OPAL BALANCE)

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ClinicalTrials.gov Identifier: NCT01976364
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis, Psoriatic
Interventions Drug: Tofacitinib
Drug: Methotrexate
Drug: Placebo Methotrexate
Enrollment 686
Recruitment Details Eligible participants (who had previously participated in randomized psoriatic arthritis [PsA] clinical studies with tofacitinib) from qualifying studies A3921091 (NCT01877668) and A3921125 (NCT01882439) were enrolled into this current study A3921092 (NCT01976364).
Pre-assignment Details This main study was a long-term extension study, which also included a sub-study (only for the purpose of efficacy, safety and tolerability of tofacitinib monotherapy as compared to tofacitinib combination therapy with methotrexate). Sub-study included eligible participants from main study who consented to take part in sub-study.
Arm/Group Title Tofacitinib Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description Participants with active psoriatic arthritis (PsA) received tofacitinib 5 milligram (mg) oral tablet, twice daily (BID) with or without allowed concomitant disease-modifying anti-rheumatic drugs (DMARDs) examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months. Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Period Title: Main Study (36 Months)
Started 686 0 0
Completed 465 0 0
Not Completed 221 0 0
Reason Not Completed
Adverse Event             63             0             0
Withdrawn due to pregnancy             5             0             0
Other             13             0             0
No longer met eligibility criteria             2             0             0
Medication error             1             0             0
Lost to Follow-up             10             0             0
Lack of Efficacy             40             0             0
Protocol Violation             13             0             0
Withdrawal by Subject             69             0             0
Death             5             0             0
Period Title: Sub-study (12 Months)
Started 0 89 [1] 90 [1]
Completed 0 83 85
Not Completed 0 6 5
Reason Not Completed
Lost to Follow-up             0             1             0
Withdrawal by Subject             0             0             1
Protocol Violation             0             1             1
Adverse Event             0             4             3
[1]
Participants from main study who consented to take part in sub-study, continued into sub-study.
Arm/Group Title Tofacitinib: All Participants
Hide Arm/Group Description All enrolled participants with PsA who were part of a prior qualifying study, and received at least one dose of open-label study medication (tofacitinib) in this study.
Overall Number of Baseline Participants 686
Hide Baseline Analysis Population Description
Safety analysis set (SAS) included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Full analysis set (FAS) and the SAS were same in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 686 participants
48.8  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 686 participants
Female
370
  53.9%
Male
316
  46.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 686 participants
American Indian or Alaska Native
0
   0.0%
Asian
21
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   0.3%
White
646
  94.2%
More than one race
17
   2.5%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage 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 were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Time Frame Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.
Arm/Group Title All Participants
Hide Arm/Group Description:
Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.
Overall Number of Participants Analyzed 686
Measure Type: Number
Unit of Measure: percentage of participants
AEs 83.7
SAEs 16.8
2.Primary Outcome
Title Number of Adverse Events (AEs) by Severity
Hide Description An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).
Time Frame Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.
Arm/Group Title All Participants
Hide Arm/Group Description:
Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.
Overall Number of Participants Analyzed 686
Measure Type: Number
Unit of Measure: adverse events
Number of adverse events: Mild 1632
Number of adverse events: Moderate 1045
Number of adverse events: Severe 136
3.Primary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Values
Hide Description Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.
Time Frame Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants enrolled in this study who were part of prior qualifying study, and who received at least 1 dose of open-label study medication in A3921092. Safety analysis include cumulative data for main and sub-study as pre-specified in protocol.Overall number of participants analyzed=participants evaluable for this measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.
Overall Number of Participants Analyzed 683
Measure Type: Count of Participants
Unit of Measure: Participants
646
  94.6%
4.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Hide Description Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.
Time Frame Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants enrolled in this study who were part of a prior qualifying study, and who received at least one dose of open-label study medication in A3921092. Safety analysis included cumulative data for main and sub-study as pre-specified in protocol.
Arm/Group Title All Participants
Hide Arm/Group Description:
Main Study: Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion. Sub-study: Participants from main study received tofacitinib 5 mg oral tablet BID with MTX capsules orally (dose range from 7.5 to 20 mg per week) or tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules, for up to 12 months.
Overall Number of Participants Analyzed 686
Measure Type: Count of Participants
Unit of Measure: Participants
9
   1.3%
5.Primary Outcome
Title Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Hide Description HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Time Frame Sub-study: Baseline (Day 1), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.0174  (0.02775) 0.0428  (0.02714)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean difference
Estimated Value 0.0255
Confidence Interval (2-Sided) 95%
-0.0513 to 0.1022
Estimation Comments [Not Specified]
6.Primary Outcome
Title Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
Hide Description PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
Time Frame Sub-study: Baseline (Day 1), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.138  (0.0805) 0.229  (0.0786)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.091
Confidence Interval (2-Sided) 95%
-0.131 to 0.313
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response
Hide Description Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time Frame Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 Number Analyzed 673 participants
66.12
(62.55 to 69.70)
Month 3 Number Analyzed 660 participants
68.79
(65.25 to 72.32)
Month 6 Number Analyzed 634 participants
70.66
(67.12 to 74.21)
Month 9 Number Analyzed 603 participants
71.48
(67.87 to 75.08)
Month 12 Number Analyzed 581 participants
74.18
(70.62 to 77.74)
Month 15 Number Analyzed 551 participants
78.04
(74.58 to 81.50)
Month 18 Number Analyzed 537 participants
77.65
(74.13 to 81.18)
Month 21 Number Analyzed 526 participants
77.00
(73.40 to 80.59)
Month 24 Number Analyzed 511 participants
76.13
(72.43 to 79.82)
Month 27 Number Analyzed 495 participants
78.18
(74.54 to 81.82)
Month 30 Number Analyzed 479 participants
80.79
(77.27 to 84.32)
Month 33 Number Analyzed 452 participants
77.88
(74.05 to 81.70)
Month 36 Number Analyzed 383 participants
77.02
(72.81 to 81.24)
8.Secondary Outcome
Title Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response
Hide Description Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time Frame Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 Number Analyzed 674 participants
45.70
(41.94 to 49.46)
Month 3 Number Analyzed 661 participants
43.27
(39.49 to 47.04)
Month 6 Number Analyzed 633 participants
47.08
(43.19 to 50.97)
Month 9 Number Analyzed 605 participants
50.41
(46.43 to 54.40)
Month 12 Number Analyzed 581 participants
50.26
(46.19 to 54.32)
Month 15 Number Analyzed 554 participants
55.42
(51.28 to 59.55)
Month 18 Number Analyzed 539 participants
55.10
(50.90 to 59.30)
Month 21 Number Analyzed 527 participants
55.41
(51.16 to 59.65)
Month 24 Number Analyzed 511 participants
57.34
(53.05 to 61.63)
Month 27 Number Analyzed 496 participants
56.05
(51.68 to 60.42)
Month 30 Number Analyzed 478 participants
60.46
(56.08 to 64.84)
Month 33 Number Analyzed 452 participants
57.96
(53.41 to 62.52)
Month 36 Number Analyzed 384 participants
58.85
(53.93 to 63.78)
9.Secondary Outcome
Title Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response
Hide Description Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time Frame Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 Number Analyzed 676 participants
24.85
(21.59 to 28.11)
Month 3 Number Analyzed 662 participants
26.13
(22.79 to 29.48)
Month 6 Number Analyzed 636 participants
30.50
(26.92 to 34.08)
Month 9 Number Analyzed 607 participants
30.81
(27.13 to 34.48)
Month 12 Number Analyzed 582 participants
32.13
(28.34 to 35.92)
Month 15 Number Analyzed 555 participants
33.87
(29.94 to 37.81)
Month 18 Number Analyzed 538 participants
36.25
(32.18 to 40.31)
Month 21 Number Analyzed 527 participants
34.35
(30.29 to 38.40)
Month 24 Number Analyzed 512 participants
35.94
(31.78 to 40.09)
Month 27 Number Analyzed 496 participants
38.10
(33.83 to 42.38)
Month 30 Number Analyzed 476 participants
41.60
(37.17 to 46.02)
Month 33 Number Analyzed 453 participants
38.19
(33.72 to 42.66)
Month 36 Number Analyzed 384 participants
37.76
(32.91 to 42.61)
10.Secondary Outcome
Title Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Time Frame Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 675 participants
-0.4373  (0.55677)
Change at Month 3 Number Analyzed 661 participants
-0.4559  (0.55104)
Change at Month 6 Number Analyzed 636 participants
-0.4755  (0.57468)
Change at Month 9 Number Analyzed 605 participants
-0.4841  (0.58294)
Change at Month 12 Number Analyzed 582 participants
-0.4782  (0.60163)
Change at Month 15 Number Analyzed 554 participants
-0.5108  (0.58277)
Change at Month 18 Number Analyzed 539 participants
-0.5116  (0.59401)
Change at Month 21 Number Analyzed 528 participants
-0.5211  (0.59568)
Change at Month 24 Number Analyzed 511 participants
-0.5068  (0.62016)
Change at Month 27 Number Analyzed 496 participants
-0.5219  (0.60833)
Change at Month 30 Number Analyzed 478 participants
-0.5356  (0.61316)
Change at Month 33 Number Analyzed 453 participants
-0.5276  (0.63803)
Change at Month 36 Number Analyzed 386 participants
-0.5476  (0.65226)
11.Secondary Outcome
Title Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Hide Description PsARC is comprised of 4 clinical improvement criteria: greater than or equal to (>=) 20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
Time Frame Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population for main study included all enrolled participants who were part of prior qualifying study, and who received at least 1 dose of tofacitinib in A3921092. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 Number Analyzed 669 participants
68.46
(64.94 to 71.98)
Month 3 Number Analyzed 657 participants
69.56
(66.04 to 73.08)
Month 6 Number Analyzed 633 participants
73.14
(69.69 to 76.60)
Month 9 Number Analyzed 599 participants
74.46
(70.97 to 77.95)
Month 12 Number Analyzed 577 participants
76.08
(72.60 to 79.56)
Month 15 Number Analyzed 547 participants
79.52
(76.14 to 82.91)
Month 18 Number Analyzed 534 participants
80.15
(76.77 to 83.53)
Month 21 Number Analyzed 522 participants
79.50
(76.04 to 82.96)
Month 24 Number Analyzed 507 participants
77.51
(73.88 to 81.15)
Month 27 Number Analyzed 494 participants
80.16
(76.65 to 83.68)
Month 30 Number Analyzed 475 participants
82.11
(78.66 to 85.55)
Month 33 Number Analyzed 449 participants
80.85
(77.21 to 84.49)
Month 36 Number Analyzed 381 participants
77.17
(72.95 to 81.38)
12.Secondary Outcome
Title Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
Time Frame Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline PGA-PsO score >0. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 660
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 649 participants
-1.1  (1.04)
Change at Month 3 Number Analyzed 636 participants
-1.1  (1.04)
Change at Month 6 Number Analyzed 610 participants
-1.2  (1.03)
Change at Month 9 Number Analyzed 578 participants
-1.2  (1.06)
Change at Month 12 Number Analyzed 559 participants
-1.1  (1.06)
Change at Month 15 Number Analyzed 532 participants
-1.2  (1.07)
Change at Month 18 Number Analyzed 516 participants
-1.2  (1.05)
Change at Month 21 Number Analyzed 506 participants
-1.2  (1.06)
Change at Month 24 Number Analyzed 488 participants
-1.3  (1.02)
Change at Month 27 Number Analyzed 478 participants
-1.3  (1.02)
Change at Month 30 Number Analyzed 462 participants
-1.3  (1.05)
Change at Month 33 Number Analyzed 434 participants
-1.3  (1.02)
Change at Month 36 Number Analyzed 372 participants
-1.2  (1.02)
13.Secondary Outcome
Title Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description PASI: combined assessment of lesion severity and body area affected into single score; range =0 (no disease) -72 (maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0 (0%) - 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1 =slight, 2 =moderate, 3 =marked, 4 =very marked. Final PASI =sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Time Frame Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline BSA >=3% and baseline PASI score >0. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 474
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 Number Analyzed 465 participants
55.05
(50.53 to 59.58)
Month 3 Number Analyzed 452 participants
57.96
(53.41 to 62.52)
Month 6 Number Analyzed 433 participants
60.74
(56.14 to 65.34)
Month 9 Number Analyzed 411 participants
61.07
(56.36 to 65.78)
Month 12 Number Analyzed 399 participants
63.16
(58.42 to 67.89)
Month 15 Number Analyzed 382 participants
65.71
(60.95 to 70.47)
Month 18 Number Analyzed 368 participants
65.22
(60.35 to 70.08)
Month 21 Number Analyzed 360 participants
69.72
(64.98 to 74.47)
Month 24 Number Analyzed 347 participants
71.47
(66.72 to 76.22)
Month 27 Number Analyzed 343 participants
70.85
(66.04 to 75.66)
Month 30 Number Analyzed 331 participants
68.58
(63.58 to 73.58)
Month 33 Number Analyzed 311 participants
70.10
(65.01 to 75.18)
Month 36 Number Analyzed 260 participants
68.08
(62.41 to 73.74)
14.Secondary Outcome
Title Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time Frame Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline BSA>=3% and baseline PASI score >0. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 474
Mean (Standard Deviation)
Unit of Measure: percent change
At Month 1 Number Analyzed 465 participants
-64.09  (57.473)
At Month 3 Number Analyzed 452 participants
-66.98  (43.647)
At Month 6 Number Analyzed 433 participants
-68.58  (44.568)
At Month 9 Number Analyzed 411 participants
-70.42  (40.617)
At Month 12 Number Analyzed 399 participants
-71.58  (42.515)
At Month 15 Number Analyzed 382 participants
-73.13  (43.653)
At Month 18 Number Analyzed 368 participants
-73.51  (40.527)
At Month 21 Number Analyzed 360 participants
-75.15  (44.182)
At Month 24 Number Analyzed 347 participants
-78.36  (34.808)
At Month 27 Number Analyzed 343 participants
-78.37  (34.405)
At Month 30 Number Analyzed 331 participants
-78.28  (30.270)
At Month 33 Number Analyzed 311 participants
-77.47  (43.952)
At Month 36 Number Analyzed 260 participants
-76.85  (31.973)
15.Secondary Outcome
Title Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time Frame Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline BSA>=3% and baseline PASI Score >0. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 474
Mean (Standard Deviation)
Unit of Measure: percent change
Induration: At Month 1 Number Analyzed 456 participants
-62.60  (62.288)
Induration: At Month 3 Number Analyzed 442 participants
-66.92  (46.898)
Induration: At Month 6 Number Analyzed 423 participants
-68.63  (46.644)
Induration: At Month 9 Number Analyzed 402 participants
-70.33  (41.960)
Induration: At Month 12 Number Analyzed 390 participants
-70.81  (48.439)
Induration: At Month 15 Number Analyzed 373 participants
-72.49  (48.644)
Induration: At Month 18 Number Analyzed 359 participants
-73.16  (40.801)
Induration: At Month 21 Number Analyzed 352 participants
-74.34  (47.617)
Induration: At Month 24 Number Analyzed 338 participants
-78.45  (36.534)
Induration: At Month 27 Number Analyzed 335 participants
-77.85  (34.297)
Induration: At Month 30 Number Analyzed 322 participants
-78.55  (31.187)
Induration: At Month 33 Number Analyzed 303 participants
-77.09  (42.305)
Induration: At Month 36 Number Analyzed 256 participants
-76.11  (35.000)
Erythema: At Month 1 Number Analyzed 464 participants
-63.60  (67.818)
Erythema: At Month 3 Number Analyzed 451 participants
-66.69  (43.013)
Erythema: At Month 6 Number Analyzed 432 participants
-67.17  (46.756)
Erythema: At Month 9 Number Analyzed 410 participants
-69.75  (42.882)
Erythema: At Month 12 Number Analyzed 398 participants
-70.45  (46.575)
Erythema: At Month 15 Number Analyzed 381 participants
-71.55  (50.406)
Erythema: At Month 18 Number Analyzed 367 participants
-73.12  (45.194)
Erythema: At Month 21 Number Analyzed 359 participants
-75.06  (45.993)
Erythema: At Month 24 Number Analyzed 346 participants
-77.40  (38.093)
Erythema: At Month 27 Number Analyzed 342 participants
-77.83  (33.877)
Erythema: At Month 30 Number Analyzed 330 participants
-77.04  (33.478)
Erythema: At Month 33 Number Analyzed 310 participants
-75.17  (53.782)
Erythema: At Month 36 Number Analyzed 259 participants
-75.72  (34.823)
Scaling: At Month 1 Number Analyzed 453 participants
-64.26  (55.848)
Scaling: At Month 3 Number Analyzed 439 participants
-66.15  (52.568)
Scaling: At Month 6 Number Analyzed 420 participants
-68.66  (49.145)
Scaling: At Month 9 Number Analyzed 399 participants
-69.09  (48.506)
Scaling: At Month 12 Number Analyzed 387 participants
-72.48  (45.755)
Scaling: At Month 15 Number Analyzed 370 participants
-73.83  (42.528)
Scaling: At Month 18 Number Analyzed 356 participants
-74.62  (39.708)
Scaling: At Month 21 Number Analyzed 348 participants
-75.11  (44.570)
Scaling: At Month 24 Number Analyzed 336 participants
-77.86  (38.041)
Scaling: At Month 27 Number Analyzed 332 participants
-79.34  (31.825)
Scaling: At Month 30 Number Analyzed 322 participants
-77.23  (37.819)
Scaling: At Month 33 Number Analyzed 302 participants
-77.94  (41.688)
Scaling: At Month 36 Number Analyzed 253 participants
-78.10  (30.391)
16.Secondary Outcome
Title Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis severity score for a participant was 0-60. Higher score indicated greater severity.
Time Frame Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline DSS >0. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 366
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 360 participants
-6.7  (7.65)
Change at Month 3 Number Analyzed 352 participants
-6.8  (7.71)
Change at Month 6 Number Analyzed 335 participants
-7.2  (7.89)
Change at Month 9 Number Analyzed 313 participants
-7.4  (7.29)
Change at Month 12 Number Analyzed 305 participants
-7.6  (7.70)
Change at Month 15 Number Analyzed 290 participants
-7.7  (7.44)
Change at Month 18 Number Analyzed 282 participants
-7.7  (7.50)
Change at Month 21 Number Analyzed 275 participants
-7.8  (7.89)
Change at Month 24 Number Analyzed 269 participants
-7.9  (7.76)
Change at Month 27 Number Analyzed 265 participants
-8.1  (7.59)
Change at Month 30 Number Analyzed 257 participants
-8.0  (7.65)
Change at Month 33 Number Analyzed 250 participants
-8.1  (7.75)
Change at Month 36 Number Analyzed 212 participants
-7.7  (7.88)
17.Secondary Outcome
Title Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Time Frame Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline LEI >0. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 458
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 449 participants
-1.5  (1.88)
Change at Month 3 Number Analyzed 437 participants
-1.6  (1.79)
Change at Month 6 Number Analyzed 418 participants
-1.7  (1.78)
Change at Month 9 Number Analyzed 398 participants
-1.8  (1.80)
Change at Month 12 Number Analyzed 380 participants
-1.7  (1.82)
Change at Month 15 Number Analyzed 364 participants
-2.0  (1.76)
Change at Month 18 Number Analyzed 347 participants
-1.9  (1.79)
Change at Month 21 Number Analyzed 340 participants
-1.9  (1.81)
Change at Month 24 Number Analyzed 327 participants
-2.0  (1.72)
Change at Month 27 Number Analyzed 317 participants
-2.0  (1.73)
Change at Month 30 Number Analyzed 306 participants
-2.0  (1.76)
Change at Month 33 Number Analyzed 288 participants
-2.0  (1.75)
Change at Month 36 Number Analyzed 253 participants
-2.1  (1.76)
18.Secondary Outcome
Title Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness was recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis.
Time Frame Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with baseline SPARCC enthesitis index >0. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 525
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 517 participants
-2.8  (3.60)
Change at Month 3 Number Analyzed 504 participants
-3.0  (3.61)
Change at Month 6 Number Analyzed 481 participants
-3.2  (3.72)
Change at Month 9 Number Analyzed 457 participants
-3.4  (3.69)
Change at Month 12 Number Analyzed 438 participants
-3.5  (3.46)
Change at Month 15 Number Analyzed 415 participants
-3.7  (3.55)
Change at Month 18 Number Analyzed 400 participants
-3.5  (3.45)
Change at Month 21 Number Analyzed 394 participants
-3.6  (3.60)
Change at Month 24 Number Analyzed 379 participants
-3.7  (3.62)
Change at Month 27 Number Analyzed 369 participants
-3.7  (3.56)
Change at Month 30 Number Analyzed 359 participants
-3.8  (3.49)
Change at Month 33 Number Analyzed 340 participants
-3.9  (3.39)
Change at Month 36 Number Analyzed 290 participants
-3.9  (3.69)
19.Secondary Outcome
Title Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity.
Time Frame Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 with presence of spondylitis at screening and baseline BASDAI Score>0 cm. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: centimeter
Change at Month 1 Number Analyzed 124 participants
-2.26  (2.367)
Change at Month 3 Number Analyzed 121 participants
-2.10  (2.278)
Change at Month 6 Number Analyzed 116 participants
-2.40  (2.371)
Change at Month 9 Number Analyzed 106 participants
-2.35  (2.254)
Change at Month 12 Number Analyzed 105 participants
-2.41  (2.371)
Change at Month 15 Number Analyzed 99 participants
-2.35  (2.547)
Change at Month 18 Number Analyzed 95 participants
-2.41  (2.640)
Change at Month 21 Number Analyzed 89 participants
-2.28  (2.582)
Change at Month 24 Number Analyzed 85 participants
-2.47  (2.640)
Change at Month 27 Number Analyzed 83 participants
-2.65  (2.658)
Change at Month 30 Number Analyzed 82 participants
-2.95  (2.672)
Change at Month 33 Number Analyzed 80 participants
-2.85  (2.671)
Change at Month 36 Number Analyzed 71 participants
-2.88  (2.521)
20.Secondary Outcome
Title Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Description BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity.
Time Frame Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092 and with presence of spondylitis at screening and baseline BASDAI score >=4 cm. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: centimeter
Change at Month 1 Number Analyzed 106 participants
-2.59  (2.324)
Change at Month 3 Number Analyzed 103 participants
-2.41  (2.227)
Change at Month 6 Number Analyzed 98 participants
-2.74  (2.350)
Change at Month 9 Number Analyzed 93 participants
-2.63  (2.175)
Change at Month 12 Number Analyzed 92 participants
-2.65  (2.364)
Change at Month 15 Number Analyzed 87 participants
-2.65  (2.487)
Change at Month 18 Number Analyzed 84 participants
-2.65  (2.652)
Change at Month 21 Number Analyzed 80 participants
-2.47  (2.602)
Change at Month 24 Number Analyzed 76 participants
-2.72  (2.616)
Change at Month 27 Number Analyzed 74 participants
-2.90  (2.640)
Change at Month 30 Number Analyzed 73 participants
-3.27  (2.596)
Change at Month 33 Number Analyzed 71 participants
-3.17  (2.589)
Change at Month 36 Number Analyzed 65 participants
-3.08  (2.459)
21.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 668 participants
6.44  (8.285)
Change at Month 6 Number Analyzed 630 participants
6.71  (8.496)
Change at Month 12 Number Analyzed 578 participants
7.23  (8.257)
Change at Month 18 Number Analyzed 534 participants
7.44  (8.729)
Change at Month 24 Number Analyzed 502 participants
7.79  (9.055)
Change at Month 30 Number Analyzed 471 participants
8.06  (8.899)
Change at Month 36 Number Analyzed 384 participants
7.77  (9.074)
22.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 668 participants
4.72  (10.480)
Change at Month 6 Number Analyzed 630 participants
4.98  (11.052)
Change at Month 12 Number Analyzed 578 participants
5.25  (11.072)
Change at Month 18 Number Analyzed 534 participants
5.53  (11.055)
Change at Month 24 Number Analyzed 502 participants
5.79  (11.122)
Change at Month 30 Number Analyzed 471 participants
5.82  (11.726)
Change at Month 36 Number Analyzed 384 participants
6.18  (11.284)
23.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
6.06  (9.425)
Change at Month 6 Number Analyzed 635 participants
6.44  (9.834)
Change at Month 12 Number Analyzed 582 participants
7.00  (9.472)
Change at Month 18 Number Analyzed 536 participants
7.31  (9.891)
Change at Month 24 Number Analyzed 505 participants
7.69  (10.280)
Change at Month 30 Number Analyzed 472 participants
7.96  (10.146)
Change at Month 36 Number Analyzed 386 participants
7.80  (10.703)
24.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 669 participants
6.19  (9.545)
Change at Month 6 Number Analyzed 631 participants
6.56  (9.650)
Change at Month 12 Number Analyzed 579 participants
6.61  (9.293)
Change at Month 18 Number Analyzed 534 participants
7.07  (10.050)
Change at Month 24 Number Analyzed 503 participants
7.46  (10.094)
Change at Month 30 Number Analyzed 473 participants
7.64  (10.041)
Change at Month 36 Number Analyzed 384 participants
7.40  (9.996)
25.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 673 participants
8.36  (9.797)
Change at Month 6 Number Analyzed 636 participants
8.52  (10.033)
Change at Month 12 Number Analyzed 582 participants
9.29  (9.777)
Change at Month 18 Number Analyzed 536 participants
9.70  (10.271)
Change at Month 24 Number Analyzed 504 participants
9.95  (10.980)
Change at Month 30 Number Analyzed 473 participants
10.21  (10.645)
Change at Month 36 Number Analyzed 386 participants
10.45  (10.627)
26.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
3.89  (8.033)
Change at Month 6 Number Analyzed 636 participants
4.09  (8.640)
Change at Month 12 Number Analyzed 582 participants
4.68  (8.652)
Change at Month 18 Number Analyzed 536 participants
4.76  (8.386)
Change at Month 24 Number Analyzed 504 participants
4.89  (8.608)
Change at Month 30 Number Analyzed 473 participants
4.81  (8.590)
Change at Month 36 Number Analyzed 386 participants
4.36  (8.847)
27.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represents better vitality.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
5.92  (10.160)
Change at Month 6 Number Analyzed 636 participants
6.03  (10.546)
Change at Month 12 Number Analyzed 582 participants
6.72  (10.367)
Change at Month 18 Number Analyzed 536 participants
6.67  (10.147)
Change at Month 24 Number Analyzed 504 participants
7.10  (10.828)
Change at Month 30 Number Analyzed 474 participants
7.62  (10.808)
Change at Month 36 Number Analyzed 386 participants
7.65  (10.403)
28.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
6.08  (11.028)
Change at Month 6 Number Analyzed 636 participants
6.51  (10.923)
Change at Month 12 Number Analyzed 582 participants
7.16  (10.932)
Change at Month 18 Number Analyzed 536 participants
6.76  (11.272)
Change at Month 24 Number Analyzed 504 participants
7.28  (11.487)
Change at Month 30 Number Analyzed 473 participants
7.64  (11.597)
Change at Month 36 Number Analyzed 386 participants
7.83  (11.977)
29.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 668 participants
5.40  (11.962)
Change at Month 6 Number Analyzed 632 participants
5.39  (12.445)
Change at Month 12 Number Analyzed 578 participants
5.73  (12.235)
Change at Month 18 Number Analyzed 534 participants
6.71  (12.647)
Change at Month 24 Number Analyzed 502 participants
6.82  (12.154)
Change at Month 30 Number Analyzed 473 participants
6.54  (12.843)
Change at Month 36 Number Analyzed 384 participants
6.95  (12.859)
30.Secondary Outcome
Title Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
4.85  (10.306)
Change at Month 6 Number Analyzed 636 participants
5.39  (10.893)
Change at Month 12 Number Analyzed 582 participants
5.56  (10.781)
Change at Month 18 Number Analyzed 536 participants
5.82  (10.730)
Change at Month 24 Number Analyzed 504 participants
6.09  (11.247)
Change at Month 30 Number Analyzed 474 participants
6.18  (11.278)
Change at Month 36 Number Analyzed 386 participants
6.37  (11.199)
31.Secondary Outcome
Title Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this outcome measure.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
-0.24  (0.529)
Change at Month 6 Number Analyzed 635 participants
-0.30  (0.540)
Change at Month 12 Number Analyzed 582 participants
-0.28  (0.511)
Change at Month 18 Number Analyzed 536 participants
-0.30  (0.538)
Change at Month 24 Number Analyzed 505 participants
-0.31  (0.545)
Change at Month 30 Number Analyzed 474 participants
-0.30  (0.526)
Change at Month 36 Number Analyzed 386 participants
-0.32  (0.555)
32.Secondary Outcome
Title Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 673 participants
-0.19  (0.547)
Change at Month 6 Number Analyzed 633 participants
-0.20  (0.530)
Change at Month 12 Number Analyzed 581 participants
-0.19  (0.532)
Change at Month 18 Number Analyzed 535 participants
-0.21  (0.522)
Change at Month 24 Number Analyzed 503 participants
-0.21  (0.534)
Change at Month 30 Number Analyzed 473 participants
-0.23  (0.533)
Change at Month 36 Number Analyzed 385 participants
-0.24  (0.589)
33.Secondary Outcome
Title Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
-0.27  (0.588)
Change at Month 6 Number Analyzed 635 participants
-0.30  (0.539)
Change at Month 12 Number Analyzed 582 participants
-0.33  (0.547)
Change at Month 18 Number Analyzed 536 participants
-0.32  (0.579)
Change at Month 24 Number Analyzed 505 participants
-0.36  (0.547)
Change at Month 30 Number Analyzed 474 participants
-0.34  (0.571)
Change at Month 36 Number Analyzed 386 participants
-0.35  (0.594)
34.Secondary Outcome
Title Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
-0.31  (0.557)
Change at Month 6 Number Analyzed 635 participants
-0.32  (0.570)
Change at Month 12 Number Analyzed 582 participants
-0.36  (0.568)
Change at Month 18 Number Analyzed 536 participants
-0.40  (0.584)
Change at Month 24 Number Analyzed 505 participants
-0.41  (0.602)
Change at Month 30 Number Analyzed 474 participants
-0.41  (0.601)
Change at Month 36 Number Analyzed 386 participants
-0.40  (0.613)
35.Secondary Outcome
Title Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this outcome measure.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
-0.23  (0.600)
Change at Month 6 Number Analyzed 635 participants
-0.26  (0.623)
Change at Month 12 Number Analyzed 582 participants
-0.25  (0.594)
Change at Month 18 Number Analyzed 536 participants
-0.26  (0.604)
Change at Month 24 Number Analyzed 505 participants
-0.29  (0.605)
Change at Month 30 Number Analyzed 473 participants
-0.31  (0.608)
Change at Month 36 Number Analyzed 386 participants
-0.29  (0.651)
36.Secondary Outcome
Title Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: millimeter
Change at Month 1 Number Analyzed 674 participants
14.12  (24.928)
Change at Month 6 Number Analyzed 636 participants
15.71  (25.871)
Change at Month 12 Number Analyzed 582 participants
16.00  (24.896)
Change at Month 18 Number Analyzed 535 participants
16.68  (24.746)
Change at Month 24 Number Analyzed 505 participants
17.43  (25.226)
Change at Month 30 Number Analyzed 473 participants
17.87  (25.363)
Change at Month 36 Number Analyzed 386 participants
18.07  (25.185)
37.Secondary Outcome
Title Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
7.0  (9.78)
Change at Month 6 Number Analyzed 636 participants
7.7  (10.13)
Change at Month 12 Number Analyzed 582 participants
7.8  (9.70)
Change at Month 18 Number Analyzed 536 participants
8.1  (10.06)
Change at Month 24 Number Analyzed 506 participants
8.3  (10.61)
Change at Month 30 Number Analyzed 474 participants
8.7  (10.93)
Change at Month 36 Number Analyzed 386 participants
9.1  (11.05)
38.Secondary Outcome
Title Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36
Hide Description FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
3.1  (4.47)
Change at Month 6 Number Analyzed 636 participants
3.4  (4.61)
Change at Month 12 Number Analyzed 582 participants
3.5  (4.48)
Change at Month 18 Number Analyzed 536 participants
3.6  (4.63)
Change at Month 24 Number Analyzed 506 participants
3.7  (4.93)
Change at Month 30 Number Analyzed 474 participants
3.9  (5.02)
Change at Month 36 Number Analyzed 386 participants
4.0  (4.90)
39.Secondary Outcome
Title Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Hide Description FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Time Frame Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS of main study included all enrolled participants who were part of a prior qualifying study, and who received at least one dose of tofacitinib in A3921092. Number analyzed =participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib
Hide Arm/Group Description:
Participants with active PsA received tofacitinib 5 mg oral tablet, BID with or without allowed concomitant DMARDs examples as methotrexate, leflunomide or sulfasalazine, as background therapy, for up to 36 months. Tofacitinib dose was increased to 10 mg BID or decreased back to 5 mg BID per investigator's discretion.
Overall Number of Participants Analyzed 686
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 674 participants
3.9  (5.98)
Change at Month 6 Number Analyzed 636 participants
4.2  (6.19)
Change at Month 12 Number Analyzed 582 participants
4.4  (5.88)
Change at Month 18 Number Analyzed 536 participants
4.5  (6.05)
Change at Month 24 Number Analyzed 506 participants
4.6  (6.34)
Change at Month 30 Number Analyzed 474 participants
4.8  (6.46)
Change at Month 36 Number Analyzed 386 participants
5.0  (6.77)
40.Secondary Outcome
Title Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12
Hide Description HAQ-DI assessed the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Time Frame Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for sub-study included all participants who were randomized to the sub-study and received at least 1 dose of (tofacitinib, MTX or placebo).
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Month 1 -0.0164  (0.02438) 0.0322  (0.02411)
Change at Month 3 0.0057  (0.02512) 0.0381  (0.02474)
Change at Month 9 0.0720  (0.03195) 0.0663  (0.03125)
Change at Month 12 0.0467  (0.02998) 0.0563  (0.02941)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0486
Confidence Interval (2-Sided) 95%
-0.0192 to 0.1163
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0325
Confidence Interval (2-Sided) 95%
-0.0372 to 0.1021
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0058
Confidence Interval (2-Sided) 95%
-0.0941 to 0.0825
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0096
Confidence Interval (2-Sided) 95%
-0.0734 to 0.0927
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12
Hide Description PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in mm, swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), SF-36 physical component summary (norm-based domain score were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and CRP in mg/L. PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
Time Frame Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for sub-study included all participants who were randomized to the sub-study and received at least 1 dose of (tofacitinib, MTX or placebo).
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Month 1 0.000  (0.0701) 0.032  (0.0696)
Change at Month 3 0.188  (0.0869) 0.165  (0.0868)
Change at Month 9 0.158  (0.0934) 0.371  (0.0912)
Change at Month 12 0.194  (0.0898) 0.133  (0.0882)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.032
Confidence Interval (2-Sided) 95%
-0.163 to 0.227
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.024
Confidence Interval (2-Sided) 95%
-0.266 to 0.219
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.213
Confidence Interval (2-Sided) 95%
-0.045 to 0.470
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.061
Confidence Interval (2-Sided) 95%
-0.309 to 0.188
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12
Hide Description PsARC was comprised of 4 clinical improvement criteria: >=20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
Time Frame Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 89 90
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 12.36 12.22
Month 3 11.24 6.67
Month 6 12.36 6.67
Month 9 12.36 10.00
Month 12 13.48 3.33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-9.76 to 9.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -4.57
Confidence Interval (2-Sided) 95%
-12.91 to 3.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -5.69
Confidence Interval (2-Sided) 95%
-14.26 to 2.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -2.36
Confidence Interval (2-Sided) 95%
-11.59 to 6.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -10.15
Confidence Interval (2-Sided) 95%
-18.16 to -2.14
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12
Hide Description The PGA-PsO is a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
Time Frame Baseline (Day 1), Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline PGA-PsO score>0.
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 41 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Month 1 -0.1  (0.10) 0.2  (0.11)
Change at Month 3 -0.1  (0.12) 0.1  (0.14)
Change at Month 6 -0.1  (0.11) 0.2  (0.12)
Change at Month 9 -0.3  (0.13) 0.2  (0.13)
Change at Month 12 0.0  (0.15) 0.3  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.0 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.1 to 0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.1 to 0.7
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12
Hide Description Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage (Head and neck = 10 handprints [1 handprint =10%], upper extremities = 20 handprints [1 handprint =5%], Trunk (including axillae and groin) = 30 handprints [1 handprint =3.33%], lower extremities (including buttocks) = 40 handprints [1 handprint =2.5%]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Time Frame Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline BSA >0%. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 47 42
Least Squares Mean (Standard Error)
Unit of Measure: percent change
At Month 1 Number Analyzed 44 participants 42 participants
28.47  (13.497) 9.04  (13.972)
At Month 3 Number Analyzed 44 participants 41 participants
43.58  (18.679) 13.47  (19.348)
At Month 6 Number Analyzed 42 participants 41 participants
41.51  (20.745) 17.19  (21.157)
At Month 9 Number Analyzed 40 participants 40 participants
35.36  (17.309) 23.72  (17.691)
At Month 12 Number Analyzed 39 participants 38 participants
34.74  (19.909) 41.75  (20.333)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.43
Confidence Interval (2-Sided) 95%
-58.06 to 19.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -30.11
Confidence Interval (2-Sided) 95%
-83.58 to 23.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -24.33
Confidence Interval (2-Sided) 95%
-83.35 to 34.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -11.64
Confidence Interval (2-Sided) 95%
-60.87 to 37.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.02
Confidence Interval (2-Sided) 95%
-49.73 to 63.77
Estimation Comments [Not Specified]
45.Secondary Outcome
Title Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Hide Description Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Time Frame Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline DSS >0. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 7 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 7 participants 1 participants
-0.4  (0.79) 0.0 [1]   (NA)
Change at Month 3 Number Analyzed 6 participants 1 participants
-0.3  (0.52) -1.0 [1]   (NA)
Change at Month 6 Number Analyzed 6 participants 1 participants
-0.3  (0.52) -1.0 [1]   (NA)
Change at Month 9 Number Analyzed 6 participants 1 participants
-0.3  (0.52) -1.0 [1]   (NA)
Change at Month 12 Number Analyzed 6 participants 1 participants
-0.3  (0.52) -1.0 [1]   (NA)
[1]
Standard deviation could not be calculated as only one participant was analyzed.
46.Secondary Outcome
Title Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Hide Description Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Time Frame Sub-study: Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline DSS >0.
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 7 1
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 14.29 0.0
Month 3 14.29 0.0
Month 6 14.29 0.0
Month 9 14.29 0.0
Month 12 14.29 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 6.25
Confidence Interval (2-Sided) 95%
-59.58 to 72.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 6.25
Confidence Interval (2-Sided) 95%
-59.58 to 72.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 6.25
Confidence Interval (2-Sided) 95%
-59.58 to 72.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 6.25
Confidence Interval (2-Sided) 95%
-59.58 to 72.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 6.25
Confidence Interval (2-Sided) 95%
-59.58 to 72.08
Estimation Comments [Not Specified]
47.Secondary Outcome
Title Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Hide Description Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Time Frame Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) and with baseline Leeds enthesitis index >0. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 15 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Month 1 Number Analyzed 15 participants 16 participants
-0.2  (0.25) -0.4  (0.24)
Change at Month 3 Number Analyzed 15 participants 15 participants
-0.3  (0.23) -0.5  (0.23)
Change at Month 6 Number Analyzed 15 participants 16 participants
-0.5  (0.29) -0.7  (0.28)
Change at Month 9 Number Analyzed 15 participants 16 participants
-0.3  (0.29) 0.0  (0.28)
Change at Month 12 Number Analyzed 15 participants 15 participants
-0.5  (0.28) -0.3  (0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.9 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.9 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.1 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.6 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.6 to 1.0
Estimation Comments [Not Specified]
48.Secondary Outcome
Title Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12
Hide Description Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Time Frame Sub-study: Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline LEI =0. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 74 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 Number Analyzed 72 participants 73 participants
0.2  (0.64) 0.1  (0.58)
Month 3 Number Analyzed 71 participants 72 participants
0.2  (0.56) 0.0  (0.24)
Month 6 Number Analyzed 69 participants 72 participants
0.2  (0.76) 0.2  (0.82)
Month 9 Number Analyzed 68 participants 71 participants
0.1  (0.24) 0.1  (0.46)
Month 12 Number Analyzed 68 participants 70 participants
0.2  (0.67) 0.1  (0.49)
49.Secondary Outcome
Title Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Hide Description Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Time Frame Sub-study: Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo) with baseline LEI >0.
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 13.33 25.00
Month 3 13.33 43.75
Month 6 26.67 56.25
Month 9 13.33 37.50
Month 12 26.67 43.75
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 11.67
Confidence Interval (2-Sided) 95%
-15.65 to 38.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 30.42
Confidence Interval (2-Sided) 95%
0.64 to 60.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 29.58
Confidence Interval (2-Sided) 95%
-3.46 to 62.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 24.17
Confidence Interval (2-Sided) 95%
-5.14 to 53.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 17.08
Confidence Interval (2-Sided) 95%
-15.96 to 50.12
Estimation Comments [Not Specified]
50.Secondary Outcome
Title Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12
Hide Description A psoriatic arthritis participant was considered with minimal disease activity if participant had >= 5 of 7 criteria: 1) tender/painful joint count less than or equals to (<=) 1; (2) swollen joint count <=1; (3) BSA <=3%; (4) Patient Assessment of Arthritis Pain (VAS) <=15 mm; (5) PtGA (VAS) <=20 mm; (6) HAQ-DI score <=0.5; (7) tender entheseal points (using LEI) <=1.
Time Frame Sub-study: Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 89 90
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 50.56 55.56
Month 3 50.56 54.44
Month 6 46.07 48.89
Month 9 42.70 46.67
Month 12 41.57 44.44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 4.99
Confidence Interval (2-Sided) 95%
-9.61 to 19.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 3.88
Confidence Interval (2-Sided) 95%
-10.74 to 18.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 2.82
Confidence Interval (2-Sided) 95%
-11.80 to 17.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 3.97
Confidence Interval (2-Sided) 95%
-10.58 to 18.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 2.87
Confidence Interval (2-Sided) 95%
-11.63 to 17.37
Estimation Comments [Not Specified]
51.Secondary Outcome
Title Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12
Hide Description 68 joints were assessed to determine joints that are considered tender or painful. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints). The 68 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for sub-study included all participants who were randomized to the sub-study and received at least one dose of the sub-study drug (tofacitinib, MTX or placebo).
Arm/Group Title Tofacitinib 5 mg BID + Methotrexate (MTX) Tofacitinib 5 mg BID + Placebo
Hide Arm/Group Description:
Participants from main study received tofacitinib 5 mg oral tablet BID along with MTX capsules orally (dose range from 7.5 to 20 mg per week) for up to 12 months.
Participants from main study received tofacitinib 5 mg oral tablet BID with MTX matched placebo capsules for up to 12 months.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: tender/painful joints
Change at Month 1 0.7  (0.37) 0.3  (0.37)
Change at Month 3 1.3  (0.44) 0.9  (0.44)
Change at Month 6 0.5  (0.37) 0.5  (0.37)
Change at Month 9 0.4  (0.33) 0.4  (0.32)
Change at Month 12 0.3  (0.32) 0.5  (0.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.5 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.6 to 0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.0 to 1.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.9 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + Methotrexate (MTX), Tofacitinib 5 mg BID + Placebo
Comments Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval