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Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study (OPAL BROADEN)

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ClinicalTrials.gov Identifier: NCT01877668
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Tofacitinib 5 mg BID
Drug: Tofacitinib 10 mg BID
Drug: Adalimumab
Drug: Placebo
Enrollment 422
Recruitment Details  
Pre-assignment Details Of 611 participants screened for entry into the study, 422 received treatment.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Hide Arm/Group Description Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks. Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Period Title: Overall Study
Started 107 [1] 104 [1] 106 [1] 52 [1] 53 [1]
Completed 96 96 94 44 43
Not Completed 11 8 12 8 10
Reason Not Completed
Death             0             0             0             1             0
No longer met study criteria             1             0             1             0             0
Insufficient clinical response             0             1             2             2             0
Lost to Follow-up             0             2             1             0             0
Withdrawal by Subject             2             0             3             2             2
Not specified             1             1             1             1             3
Protocol Violation             1             1             0             0             3
Adverse event related to study drug             2             2             2             2             1
Adverse event unrelated to study drug             4             1             2             0             1
[1]
Received treatment
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Total
Hide Arm/Group Description Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks. Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 107 104 106 52 53 422
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 104 participants 106 participants 52 participants 53 participants 422 participants
49.4  (12.6) 46.9  (12.4) 47.4  (11.3) 46.1  (10.4) 49.3  (13.8) 47.9  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 104 participants 106 participants 52 participants 53 participants 422 participants
Female
57
  53.3%
62
  59.6%
50
  47.2%
28
  53.8%
28
  52.8%
225
  53.3%
Male
50
  46.7%
42
  40.4%
56
  52.8%
24
  46.2%
25
  47.2%
197
  46.7%
1.Primary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3
Hide Description ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).
Time Frame At end of Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 105
Measure Type: Number
Unit of Measure: Percentage or participants
50.47 60.58 51.89 33.33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 5 mg, Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments [Not Specified]
Method Large sample approximation
Comments Missing response (MR)=non-response (NR)
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.13
Confidence Interval (2-Sided) 95%
4.06 to 30.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 10 mg, Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Large sample approximation
Comments MR=NR
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.24
Confidence Interval (2-Sided) 95%
14.22 to 40.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.64
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab, 40 mg, Every 2 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Large sample approximation
Comments MR=NR
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.55
Confidence Interval (2-Sided) 95%
5.45 to 31.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.69
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Hide Description The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
Time Frame From Baseline to Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.3499  (0.04665) -0.3998  (0.04716) -0.3808  (0.04767) -0.1802  (0.05031)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 5 mg, Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Mixed Models Analysis
Comments No imputation.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1697
Confidence Interval (2-Sided) 95%
-0.2910 to -0.0483
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06173
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 10 mg, Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments No imputation.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2196
Confidence Interval (2-Sided) 95%
-0.3411 to -0.0980
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06184
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab, 40 mg, Every 2 Weeks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Mixed Models Analysis
Comments No imputation.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2005
Confidence Interval (2-Sided) 95%
-0.3213 to -0.0797
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06145
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis
Hide Description Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.
Time Frame From Baseline to Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Overall Number of Participants Analyzed 98 99 95 48 45
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.01  (0.067) -0.01  (0.067) -0.07  (0.069) 0.00  (0.094) 0.09  (0.099)
4.Secondary Outcome
Title Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12
Hide Description Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline.
Time Frame At Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Overall Number of Participants Analyzed 98 99 95 48 45
Measure Type: Number
Unit of Measure: Percentage of participants
4.08 5.05 2.11 4.17 8.89
5.Secondary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Hide Description ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
Time Frame At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 52 53 105
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=7, 7, 5, NA, NA, 1) 6.54 6.73 4.72 NA [1]  NA [1]  0.95
Month 1 (n=13, 20,12, NA, NA, 5) 12.15 19.23 11.32 NA [1]  NA [1]  4.76
Month 2 (n=23, 34, 24, NA, NA, 8) 21.50 32.69 22.64 NA [1]  NA [1]  7.62
Month 3 (n=30, 42, 35, NA, NA, 10) 28.04 40.38 33.02 NA [1]  NA [1]  9.52
Month 4 (n=38, 39, 34, 11, 17, NA) 35.51 37.50 32.08 21.15 32.08 NA [1] 
Month 6 (n=41, 48, 45, 17, 14, NA) 38.32 46.15 42.45 32.69 26.42 NA [1] 
Month 9 (n=45, 48, 49, 22, 23, NA) 42.06 46.15 46.23 42.31 43.40 NA [1] 
Month 12 (n=48, 50, 43, 21, 19, NA) 44.86 48.08 40.57 40.38 35.85 NA [1] 
[1]
Results not reported for this group.
6.Secondary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Hide Description

ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.

Time Frame At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 52 53 105
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=0, 3, 1, NA, NA, 0) 0.00 2.88 0.94 NA [1]  NA [1]  0.00
Month 1 (n=5, 8, 4, NA, NA, 1) 4.67 7.69 3.77 NA [1]  NA [1]  0.95
Month 2 (n=10, 14, 13, NA, NA, 2) 9.35 13.46 12.26 NA [1]  NA [1]  1.90
Month 3 (n=18, 15, 20, NA, NA, 5) 16.82 14.42 18.87 NA [1]  NA [1]  4.76
Month 4 (n=24, 23, 21, 7, 8, NA) 22.43 22.12 19.81 13.46 15.09 NA [1] 
Month 6 (n=19, 33, 32, 10, 7, NA) 17.76 31.73 30.19 19.23 13.21 NA [1] 
Month 9 (n=21, 31, 30, 15, 12, NA) 19.63 29.81 28.30 28.85 22.64 NA [1] 
Month 12 (n=25, 32, 31, 12, 12, NA) 23.36 30.77 29.25 23.08 22.64 NA [1] 
[1]
Results not reported for this group.
7.Secondary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12
Hide Description ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
Time Frame At Week 2 and Months 1, 2, 4, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 52 53 105
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=24, 33, 23, NA, NA, 6) 22.43 31.73 21.70 NA [1]  NA [1]  5.71
Month 1 (n=37, 50, 30, NA, NA, 11) 34.58 48.08 28.30 NA [1]  NA [1]  10.48
Month 2 (n=47, 57, 62, NA, NA, 28) 43.93 54.81 58.49 NA [1]  NA [1]  26.67
Month 4 (n=65, 60, 61, 27, 28, NA) 60.75 57.69 57.55 51.92 52.83 NA [1] 
Month 6 (n=63, 70, 68, 31, 30, NA) 58.88 67.31 64.15 59.62 56.60 NA [1] 
Month 9 (n=73, 76, 73, 35, 37, NA) 68.22 73.08 68.87 67.31 69.81 NA [1] 
Month 12 (n=73, 73, 64, 35, 31, NA) 68.22 70.19 60.38 67.31 58.49 NA [1] 
[1]
Results not reported for this group.
8.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Hide Description The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
Time Frame From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n=106, 102, 103, NA, NA, 102) -0.1842  (0.04131) -0.2089  (0.04208) -0.2129  (0.04246) NA [1]   (NA) NA [1]   (NA) -0.0837  (0.04549)
Month 1 (n=105, 103, 104, NA, NA, 103) -0.2048  (0.04363) -0.2676  (0.04426) -0.3028  (0.04465) NA [1]   (NA) NA [1]   (NA) -0.1224  (0.04755)
Month 2 (n=104, 104, 104, NA, NA, 102) -0.2713  (0.04626) -0.4009  (0.04678) -0.3736  (0.04719) NA [1]   (NA) NA [1]   (NA) -0.1682  (0.04998)
Month 4 (n=102, 100, 102, 50, 50, NA) -0.4231  (0.04982) -0.4407  (0.05039) -0.3643  (0.05069) -0.2850  (0.07075) -0.3302  (0.07128) NA [1]   (NA)
Month 6 (n=100, 100, 99, 48, 48, NA) -0.4471  (0.05136) -0.4611  (0.05179) -0.4259  (0.05227) -0.3142  (0.07315) -0.3841  (0.07369) NA [1]   (NA)
Month 9 (n=99, 96, 96, 47, 45, NA) -0.5119  (0.05038) -0.4847  (0.05096) -0.4304  (0.05143) -0.3843  (0.07185) -0.4839  (0.07276) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) -0.5391  (0.05324) -0.5104  (0.05365) -0.4478  (0.05426) -0.4104  (0.07646) -0.4569  (0.07704) NA [1]   (NA)
[1]
Results were not reported for this group.
9.Secondary Outcome
Title Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame From Baseline to end of Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 104
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
-5.5981  (0.80656) -6.6004  (0.80822) -7.8955  (0.82547) -0.8643  (0.86304)
10.Secondary Outcome
Title Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain
Hide Description Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time Frame From Baseline to end of Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 105 104
Least Squares Mean (Standard Error)
Unit of Measure: mm
-21.49  (2.325) -27.10  (2.342) -21.87  (2.389) -10.22  (2.499)
11.Secondary Outcome
Title Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis
Hide Description Participant answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).
Time Frame From Baseline to end of Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 104
Least Squares Mean (Standard Error)
Unit of Measure: mm
-20.08  (2.275) -25.50  (2.291) -21.47  (2.328) -11.40  (2.439)
12.Secondary Outcome
Title Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis
Hide Description The blinded investigator or qualified assessor assessed how the participant’s overall arthritis appeared at the time of the visit. This was an evaluation based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Time Frame From Baseline to end of Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 103 106 104
Least Squares Mean (Standard Error)
Unit of Measure: mm
-27.44  (1.998) -33.74  (2.021) -29.02  (2.043) -22.26  (2.121)
13.Secondary Outcome
Title Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count
Hide Description Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.
Time Frame From Baseline to end of Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 104
Least Squares Mean (Standard Error)
Unit of Measure: Joints
-6.5  (0.58) -7.6  (0.58) -6.5  (0.59) -4.8  (0.62)
14.Secondary Outcome
Title Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count
Hide Description Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.
Time Frame From Baseline to end of Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 104
Least Squares Mean (Standard Error)
Unit of Measure: Joints
-8.7  (1.04) -11.0  (1.05) -7.6  (1.07) -6.9  (1.10)
15.Secondary Outcome
Title Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Hide Description The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician’s Global Assessment of Arthritis, and the Patient’s Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician’s Global Assessment of Arthritis; ≥20% improvement in Patient’s Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.
Time Frame At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 107 104 106 52 53 105
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=34, 42, 23, NA, NA, 10) 31.78 40.38 21.70 NA [1]  NA [1]  9.52
Month 1 (n=45, 51, 43, NA, NA, 23) 42.06 49.04 40.57 NA [1]  NA [1]  21.90
Month 2 (n=54, 69, 62, NA, NA, 36) 50.47 66.35 58.49 NA [1]  NA [1]  34.29
Month 3 (n=55, 73, 65, NA, NA, 47) 51.40 70.19 61.32 NA [1]  NA [1]  44.76
Month 4 (n=68, 68, 71, 32, 30, NA) 63.55 65.38 66.98 61.54 56.60 NA [1] 
Month 6 (n=61, 75, 71, 35, 35, NA) 57.01 72.12 66.98 67.31 66.04 NA [1] 
Month 9 (n=75, 73, 71, 36, 37, NA) 70.09 70.19 66.98 69.23 69.81 NA [1] 
Month 12 (n=69, 76, 69, 39, 33, NA) 64.49 73.08 65.09 75.00 62.26 NA [1] 
[1]
Results not reported for this group.
16.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response
Hide Description The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO>0 and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 101 98 102 50 50 100
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=100, 96, 100, NA, NA, 99) -0.7  (0.07) -0.8  (0.08) -0.5  (0.08) NA [1]   (NA) NA [1]   (NA) -0.2  (0.08)
Month 3 (n=98, 97, 98, NA, NA, 98) -1.0  (0.08) -1.2  (0.08) -1.0  (0.09) NA [1]   (NA) NA [1]   (NA) -0.4  (0.09)
Month 6 (n=96, 94, 96, 46, 46, NA) -0.9  (0.09) -1.3  (0.09) -1.2  (0.09) -0.7  (0.12) -0.9  (0.13) NA [1]   (NA)
Month 9 (n=95, 91, 94, 45, 44, NA) -1.0  (0.09) -1.5  (0.09) -1.2  (0.09) -0.7  (0.12) -1.3  (0.13) NA [1]   (NA)
Month 12 (n=91, 90, 92, 41, 43, NA) -1.2  (0.09) -1.5  (0.09) -1.2  (0.09) -0.9  (0.13) -1.3  (0.13) NA [1]   (NA)
[1]
Results not reported for this group.
17.Secondary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12
Hide Description PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.
Time Frame At Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug with PASI>0 and BSA ≥3% at baseline. n=number of responders.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 82 70 77 42 40 82
Measure Type: Number
Unit of Measure: Percentage of participants
Month 1 (n=19, 19, 11, NA, NA, 4) 23.17 27.14 14.29 NA [1]  NA [1]  4.88
Month 3 (n=35, 31, 30, NA, NA, 12) 42.68 44.29 38.96 NA [1]  NA [1]  14.63
Month 6 (n=38, 42, 42, 12, 17, NA) 46.34 60.00 54.55 28.57 42.50 NA [1] 
Month 9 (n=36, 48, 45, 14, 20, NA) 43.90 68.57 58.44 33.33 50.00 NA [1] 
Month 12 (n=46, 47, 43, 15, 21, NA) 56.10 67.14 55.84 35.71 52.50 NA [1] 
[1]
Results not reported for this group.
18.Secondary Outcome
Title Change From Baseline in Dactylitis Severity Score (DSS)
Hide Description Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is 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 scores for a patient is 0-60. Higher score indicates greater degree of tenderness.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline DSS>0 and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 60 60 58 29 28 57
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=58, 59, 56, NA, NA, 56) -1.8  (0.91) -3.1  (0.87) -2.1  (0.93) NA [1]   (NA) NA [1]   (NA) 0.6  (1.02)
Month 3 (n=58, 60 , 56, NA, NA, 55) -3.5  (0.95) -5.5  (0.91) -4.0  (0.97) NA [1]   (NA) NA [1]   (NA) -2.0  (1.06)
Month 6 (n=58, 59, 55, 28, 25, NA) -5.2  (1.01) -6.4  (0.99) -5.4  (1.03) -5.9  (1.45) -5.2  (1.50) NA [1]   (NA)
Month 9 (n=57, 59, 53, 27, 25, NA) -7.0  (0.60) -7.2  (0.58) -6.5  (0.63) -5.3  (0.87) -7.9  (0.89) NA [1]   (NA)
Month 12 (n=54, 58, 52, 26, 24, NA) -7.4  (0.65) -7.5  (0.62) -6.1  (0.67) -6.7  (0.93) -7.7  (0.96) NA [1]   (NA)
[1]
Results not reported for this group.
19.Secondary Outcome
Title Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Hide Description The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is 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 indicates a greater number of sites that are affected by enthesitis.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score>0 and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 80 81 82 38 41 79
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=79, 80, 80, NA, NA, 78) -0.83  (0.317) -1.27  (0.321) -0.95  (0.336) NA [1]   (NA) NA [1]   (NA) -0.58  (0.355)
Month 3 (n=77, 79, 79, NA, NA, 78) -1.84  (0.363) -2.41  (0.364) -1.90  (0.375) NA [1]   (NA) NA [1]   (NA) -1.17  (0.393)
Month 6 (n=76, 78, 76, 33, 39, NA) -2.4  (0.34) -2.6  (0.34) -2.3  (0.35) -2.4  (0.50) -2.5  (0.48) NA [1]   (NA)
Month 9 (n=75, 75, 73, 34, 37, NA) -2.9  (0.31) -2.6  (0.32) -3.0  (0.33) -2.8  (0.46) -3.2  (0.44) NA [1]   (NA)
Month 12 (n=72, 73, 72, 31, 37, NA) -3.2  (0.33) -3.1  (0.33) -2.8  (0.35) -2.5  (0.49) -3.2  (0.46) NA [1]   (NA)
[1]
Results not reported for this group.
20.Secondary Outcome
Title Change From Baseline in the Leeds Enthesitis Index (LEI)
Hide Description Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0–6. Higher score indicates a greater number of sites that are affected by enthesitis.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline LEI>0 and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 74 64 76 31 34 65
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=74, 63, 75, NA, NA, 65) -0.41  (0.192) -0.57  (0.213) -0.42  (0.203) NA [1]   (NA) NA [1]   (NA) -0.26  (0.219)
Month 3 (n=70, 63, 73, NA, NA, 63) -0.82  (0.221) -1.46  (0.240) -1.10  (0.228) NA [1]   (NA) NA [1]   (NA) -0.43  (0.246)
Month 6 (n=72, 61, 71, 27, 31, NA) -1.3  (0.21) -1.2  (0.23) -1.3  (0.22) -1.0  (0.32) -1.3  (0.30) NA [1]   (NA)
Month 9 (n=70, 58, 68, 27, 29, NA) -1.4  (0.20) -1.3  (0.23) -1.5  (0.21) -1.4  (0.31) -1.7  (0.30) NA [1]   (NA)
Month 12 (n=67, 56, 67, 24, 29, NA) -1.7  (0.19) -1.6  (0.21) -1.6  (0.20) -1.4  (0.30) -1.9  (0.28) NA [1]   (NA)
[1]
Results not reported for this group.
21.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score
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. An additional item measures health transition. The 8 health domains are 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 are 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 represents better physical health status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 3.39  (0.638) 4.66  (0.645) 4.00  (0.655) NA [1]   (NA) NA [1]   (NA) 1.54  (0.700)
Month 3 (n=102, 103,100, NA, NA, 102) 5.51  (0.733) 5.69  (0.735) 6.23  (0.748) NA [1]   (NA) NA [1]   (NA) 2.68  (0.785)
Month 6 (n=100, 100, 98, 48, 48, NA) 6.72  (0.773) 6.70  (0.777) 6.26  (0.788) 5.86  (1.101) 6.07  (1.112) NA [1]   (NA)
Month 9 (n=99, 97, 95, 47, 46, NA) 7.52  (0.781) 7.21  (0.787) 6.91  (0.798) 6.16  (1.115) 7.15  (1.130) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 43, NA) 7.61  (0.806) 7.67  (0.810) 6.74  (0.822) 5.82  (1.160) 5.72  (1.177) NA [1]   (NA)
[1]
Results not reported for this group.
22.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score
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. An additional item measures health transition. 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 From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104,NA, NA, 103) 4.12  (0.841) 3.63  (0.849) 2.13  (0.871) NA [1]   (NA) NA [1]   (NA) 3.19  (0.917)
Month 3 (n=102, 103,100, NA, NA, 102) 4.35  (0.909) 4.20  (0.909) 3.13  (0.938) NA [1]   (NA) NA [1]   (NA) 3.27  (0.976)
Month 6 (n=100, 100, 98, 48, 48, NA) 5.70  (0.927) 5.51  (0.930) 4.58  (0.955) 4.50  (1.319) 3.62  (1.331) NA [1]   (NA)
Month 9 (n=99, 97, 95, 47, 46, NA) 5.07  (0.974) 6.20  (0.982) 3.68  (1.005) 4.61  (1.391) 6.03  (1.409) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 43, NA) 4.82  (1.012) 6.26  (1.016) 4.81  (1.039) 4.51  (1.455) 4.43  (1.474) NA [1]   (NA)
[1]
Results not reported for this group.
23.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain
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. An additional item measures health transition. 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 physical functioning domain score represents better physical functioning.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 2.43  (0.768) 3.89  (0.776) 2.81  (0.787) NA [1]   (NA) NA [1]   (NA) 1.10  (0.840)
Month 3 (n=102, 103,101, NA, NA, 102) 5.17  (0.846) 5.23  (0.848) 5.22  (0.862) NA [1]   (NA) NA [1]   (NA) 2.06  (0.910)
Month 6 (n=100, 100, 99, 48, 48, NA) 7.02  (0.897) 6.15  (0.900) 6.36  (0.912) 5.22  (1.276) 5.22  (1.291) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 7.43  (0.902) 6.67  (0.909) 7.01  (0.921) 5.69  (1.285) 6.25  (1.306) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 7.67  (0.899) 7.11  (0.903) 6.81  (0.917) 6.49  (1.292) 4.77  (1.308) NA [1]   (NA)
[1]
Results were not reported for this group.
24.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain
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. An additional item measures health transition. 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 role-physical domain score represents better role-physical functioning.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 4.05  (0.751) 3.72  (0.759) 4.09  (0.770) NA [1]   (NA) NA [1]   (NA) 1.98  (0.820)
Month 3 (n=102, 103, 100, NA, NA, 102) 4.45  (0.801) 4.79  (0.803) 5.21  (0.820) NA [1]   (NA) NA [1]   (NA) 3.63  (0.862)
Month 6 (n=100, 100, 99, 48, 48, NA) 6.02  (0.824) 5.21  (0.828) 5.48  (0.840) 4.97  (1.172) 5.03  (1.185) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 6.24  (0.853) 6.56  (0.861) 5.79  (0.872) 4.68  (1.217) 6.70  (1.234) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 6.21  (0.888) 7.11  (0.892) 6.37  (0.906) 2.98  (1.279) 5.03  (1.291) NA [1]   (NA)
[1]
Results were not reported for this group.
25.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain
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. An additional item measures health transition. 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 bodily pain domain score represents less bodily pain.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 5.53  (0.777) 7.16  (0.786) 6.42  (0.802) NA [1]   (NA) NA [1]   (NA) 3.44  (0.851)
Month 3 (n=102, 103, 101, NA, NA, 102) 7.75  (0.838) 8.05  (0.840) 7.52  (0.859) NA [1]   (NA) NA [1]   (NA) 3.77  (0.903)
Month 6 (n=100, 100, 99, 48, 48, NA) 7.76  (0.985) 10.65  (0.989) 7.76  (1.004) 8.55  (1.405) 8.98  (1.425) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 9.03  (0.953) 10.13  (0.960) 8.59  (0.977) 8.46  (1.362) 10.81  (1.389) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 43, NA) 9.15  (0.961) 11.38  (0.965) 9.18  (0.984) 8.59  (1.384) 8.61  (1.413) NA [1]   (NA)
[1]
Results were not reported for this group.
26.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain
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. An additional item measures health transition. 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 general health domain score represents better general health perceptions.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 3.29  (0.610) 3.87  (0.616) 1.96  (0.625) NA [1]   (NA) NA [1]   (NA) 2.15  (0.666)
Month 3 (n=102, 103,101, NA, NA, 102 ) 4.09  (0.700) 3.95  (0.701) 4.73  (0.713) NA [1]   (NA) NA [1]   (NA) 2.64  (0.748)
Month 6 (n=100, 100, 99, 48, 48, NA) 5.96  (0.720) 4.12  (0.722) 4.81  (0.733) 4.39  (1.022) 3.92  (1.033) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 5.93  (0.773) 5.18  (0.778) 4.09  (0.788) 4.72  (1.102) 4.85  (1.117) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 5.70  (0.811) 4.63  (0.815) 4.21  (0.825) 4.50  (1.164) 4.12  (1.175) NA [1]   (NA)
[1]
Results were not reported for this group.
27.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain
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. An additional item measures health transition. 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 vitality domain score represents better vitality.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 3.64  (0.802) 4.59  (0.806) 2.42  (0.826) NA [1]   (NA) NA [1]   (NA) 2.16  (0.877)
Month 3 (n=102, 103, 101, NA, NA, 102) 5.50  (0.889) 5.90  (0.887) 4.93  (0.909) NA [1]   (NA) NA [1]   (NA) 3.05  (0.954)
Month 6 (n=100, 100, 99, 48, 48, NA) 6.81  (0.969) 7.41  (0.970) 5.05  (0.989) 5.34  (1.378) 4.62  (1.394) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 6.09  (1.017) 7.82  (1.023) 5.27  (1.041) 6.61  (1.451) 6.39  (1.472) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 7.01  (1.022) 7.02  (1.024) 5.12  (1.043) 5.62  (1.465) 5.15  (1.481) NA [1]   (NA)
[1]
Results were not reported for this group.
28.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain
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. An additional item measures health transition. 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 social functioning domain score represents better social functioning.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 4.51  (0.827) 4.46  (0.838) 3.34  (0.852) NA [1]   (NA) NA [1]   (NA) 2.96  (0.901)
Month 3 (n=102, 103, 101, NA, NA, 102) 5.95  (0.897) 5.22  (0.898) 5.26  (0.918) NA [1]   (NA) NA [1]   (NA) 3.63  (0.961)
Month 6 (n=100, 100, 99, 48, 48, NA) 6.97  (0.955) 7.08  (0.959) 7.10  (0.975) 5.44  (1.362) 6.05  (1.373) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 7.66  (0.947) 7.74  (0.957) 5.69  (0.972) 5.95  (1.355) 8.93  (1.373) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 6.13  (0.989) 8.42  (0.995) 6.32  (1.012) 6.19  (1.427) 6.41  (1.445) NA [1]   (NA)
[1]
Results were not reported for this group.
29.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain
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. An additional item measures health transition. 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 role-emotional domain score represents better role-emotional functioning.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103,104, NA, NA, 103) 4.77  (0.960) 3.87  (0.971) 2.93  (0.991) NA [1]   (NA) NA [1]   (NA) 4.52  (1.042)
Month 3 (n=102, 103, 100, NA, NA, 102) 4.21  (1.010) 4.82  (1.011) 3.35  (1.040) NA [1]   (NA) NA [1]   (NA) 3.68  (1.083)
Month 6 (n=100, 100, 98, 48, 48, NA) 5.67  (1.024) 4.68  (1.027) 4.77  (1.051) 6.34  (1.458) 4.56  (1.473) NA [1]   (NA)
Month 9 (n=99, 97, 95, 47, 46, NA) 5.13  (1.021) 6.13  (1.030) 4.87  (1.052) 5.89  (1.456) 6.52  (1.478) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 5.15  (1.048) 6.73  (1.053) 6.03  (1.075) 4.77  (1.509) 4.94  (1.525) NA [1]   (NA)
[1]
Results not reported for this group.
30.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain
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. An additional item measures health transition. 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 mental health domain score represents better mental health functioning.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103, 104, NA, NA, 103) 3.32  (0.867) 3.87  (0.874) 2.79  (0.895) NA [1]   (NA) NA [1]   (NA) 1.57  (0.952)
Month 3 (n=102, 103, 101, NA, NA, 102) 4.45  (0.934) 4.23  (0.932) 3.95  (0.956) NA [1]   (NA) NA [1]   (NA) 2.62  (1.009)
Month 6 (n=100, 100, 99, 48, 48, NA) 6.11  (0.951) 6.38  (0.953) 5.35  (0.974) 3.70  (1.354) 3.41  (1.372) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 5.79  (1.022) 6.43  (1.028) 4.62  (1.048) 3.57  (1.461) 5.45  (1.483) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 5.86  (1.019) 6.58  (1.022) 5.86  (1.044) 4.72  (1.467) 4.48  (1.483) NA [1]   (NA)
[1]
Results were not reported for this group.
31.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103, 104, NA, NA, 103) -0.07  (0.042) -0.19  (0.043) -0.15  (0.043) NA [1]   (NA) NA [1]   (NA) -0.10  (0.046)
Month 3 (n=101, 103, 101, NA, NA, 102) -0.28  (0.047) -0.27  (0.047) -0.29  (0.048) NA [1]   (NA) NA [1]   (NA) -0.11  (0.050)
Month 6 (n=100, 100, 99, 48, 48, NA) -0.3  (0.05) -0.3  (0.05) -0.2  (0.05) -0.3  (0.07) -0.2  (0.07) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) -0.3  (0.05) -0.3  (0.05) -0.3  (0.05) -0.3  (0.07) -0.3  (0.07) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44,44, NA) -0.3  (0.05) -0.3  (0.05) -0.3  (0.05) -0.4  (0.07) -0.3  (0.07) NA [1]   (NA)
[1]
Results were not reported for this group.
32.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 103 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 102, 104, NA, NA, 103) -0.11  (0.046) -0.16  (0.047) -0.16  (0.047) NA [1]   (NA) NA [1]   (NA) -0.09  (0.050)
Month 3 (n=101, 102, 101, NA, NA, 102) -0.19  (0.047) -0.11  (0.047) -0.18  (0.048) NA [1]   (NA) NA [1]   (NA) -0.12  (0.051)
Month 6 (n=100, 99, 99, 48, 48, NA) -0.2  (0.04) -0.3  (0.05) -0.2  (0.05) -0.2  (0.06) -0.3  (0.06) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) -0.2  (0.05) -0.2  (0.05) -0.3  (0.05) -0.2  (0.06) -0.3  (0.07) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) -0.2  (0.05) -0.3  (0.05) -0.3  (0.05) -0.3  (0.07) -0.2  (0.07) NA [1]   (NA)
[1]
Results were not reported for this group.
33.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 103 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 102, 104, NA, NA, 103) -0.17  (0.043) -0.19  (0.043) -0.21  (0.044) NA [1]   (NA) NA [1]   (NA) -0.06  (0.047)
Month 3 (n=101, 102, 101, NA, NA, 102) -0.24  (0.049) -0.29  (0.049) -0.29  (0.049) NA [1]   (NA) NA [1]   (NA) -0.17  (0.052)
Month 6 (n=100, 99, 99, 48, 47, NA) -0.3  (0.05) -0.3  (0.05) -0.4  (0.05) -0.3  (0.07) -0.3  (0.07) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) -0.3  (0.05) -0.4  (0.05) -0.4  (0.05) -0.3  (0.07) -0.4  (0.07) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) -0.3  (0.05) -0.4  (0.05) -0.4  (0.05) -0.3  (0.07) -0.3  (0.07) NA [1]   (NA)
[1]
Results were not reported for this group.
34.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103, 104, NA, NA, 103) -0.14  (0.039) -0.25  (0.040) -0.19  (0.040) NA [1]   (NA) NA [1]   (NA) -0.08  (0.043)
Month 3 (n=101, 103, 101, NA, NA, 102) -0.25  (0.044) -0.27  (0.044) -0.28  (0.045) NA [1]   (NA) NA [1]   (NA) -0.08  (0.047)
Month 6 (n=100, 100, 99, 48, 48, NA) -0.3  (0.05) -0.4  (0.05) -0.3  (0.05) -0.3  (0.07) -0.4  (0.07) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) -0.3  (0.05) -0.3  (0.05) -0.3  (0.05) -0.4  (0.07) -0.4  (0.07) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) -0.3  (0.05) -0.4  (0.05) -0.3  (0.05) -0.2  (0.07) -0.3  (0.07) NA [1]   (NA)
[1]
Results were not reported for this group.
35.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103, 104, NA, NA, 103) -0.25  (0.051) -0.22  (0.052) -0.27  (0.053) NA [1]   (NA) NA [1]   (NA) -0.21  (0.056)
Month 3 (n=101, 103, 100, NA, NA, 102) -0.25  (0.055) -0.17  (0.055) -0.32  (0.056) NA [1]   (NA) NA [1]   (NA) -0.21  (0.059)
Month 6 (n=100, 100, 99, 48, 48, NA) -0.3  (0.05) -0.3  (0.05) -0.3  (0.05) -0.3  (0.08) -0.2  (0.08) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) -0.3  (0.05) -0.4  (0.05) -0.4  (0.06) -0.2  (0.08) -0.3  (0.08) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) -0.3  (0.05) -0.4  (0.05) -0.4  (0.06) -0.2  (0.08) -0.3  (0.08) NA [1]   (NA)
[1]
Results were not reported for this group.
36.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: mm
Month 1 (n=105, 103, 104, NA, NA, 103) 10.75  (1.859) 10.81  (1.880) 10.27  (1.917) NA [1]   (NA) NA [1]   (NA) 6.59  (2.027)
Month 3 (n=101, 103, 101, NA, NA, 101) 14.00  (2.100) 15.83  (2.092) 13.10  (2.138) NA [1]   (NA) NA [1]   (NA) 6.37  (2.242)
Month 6 (n=100, 100, 99, 48, 48, NA) 19.5  (2.08) 15.7  (2.09) 15.5  (2.12) 14.7  (2.97) 16.6  (3.00) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 19.2  (2.21) 15.9  (2.23) 18.2  (2.26) 12.8  (3.16) 21.5  (3.21) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 20.7  (2.09) 19.8  (2.09) 16.5  (2.14) 16.0  (3.02) 19.8  (3.05) NA [1]   (NA)
[1]
Results were not reported for this group.
37.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score
Hide Description FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103, 104, NA, NA, 103) 5.2  (0.77) 4.4  (0.78) 4.2  (0.79) NA [1]   (NA) NA [1]   (NA) 2.7  (0.84)
Month 3 (102, 102, 101, NA, NA, 102) 7.0  (0.85) 6.0  (0.85) 6.0  (0.87) NA [1]   (NA) NA [1]   (NA) 3.3  (0.91)
Month 6 (n=100, 100, 99,48, 48, NA) 7.9  (0.89) 8.0  (0.89) 6.5  (0.91) 6.5  (1.26) 7.2  (1.28) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 7.9  (0.92) 7.4  (0.92) 6.5  (0.94) 5.5  (1.31) 8.4  (1.33) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 8.5  (0.95) 8.4  (0.95) 6.9  (0.97) 5.7  (1.36) 7.6  (1.38) NA [1]   (NA)
[1]
Results were not reported for this group.
38.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score
Hide Description FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103, 104, NA, NA, 103) 2.4  (0.35) 2.1  (0.35) 2.1  (0.36) NA [1]   (NA) NA [1]   (NA) 1.2  (0.38)
Month 3 (n=102, 102, 101, NA, NA, 102) 3.3  (0.38) 2.8  (0.38) 2.9  (0.39) NA [1]   (NA) NA [1]   (NA) 1.6  (0.41)
Month 6 (n=100, 100, 99,48, 48, NA) 3.6  (0.40) 3.3  (0.40) 3.2  (0.41) 3.0  (0.57) 3.3  (0.58) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 3.6  (0.42) 3.3  (0.42) 3.3  (0.43) 2.7  (0.59) 3.9  (0.60) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 3.9  (0.44) 3.7  (0.44) 3.2  (0.45) 2.7  (0.63) 3.4  (0.63) NA [1]   (NA)
[1]
Results were not reported for this group.
39.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score
Hide Description FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 106 104 106 52 52 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=105, 103, 104, NA, NA, 103) 2.9  (0.47) 2.3  (0.48) 2.1  (0.49) NA [1]   (NA) NA [1]   (NA) 1.5  (0.52)
Month 3 (n=102, 102, 101, NA, NA, 102) 3.8  (0.52) 3.2  (0.52) 3.2  (0.53) NA [1]   (NA) NA [1]   (NA) 1.8  (0.56)
Month 6 (n=100, 100, 99,48, 48, NA) 4.3  (0.53) 4.7  (0.53) 3.4  (0.54) 3.5  (0.75) 4.0  (0.76) NA [1]   (NA)
Month 9 (n=99, 97, 96, 47, 46, NA) 4.3  (0.55) 4.1  (0.55) 3.3  (0.56) 2.8  (0.78) 4.6  (0.80) NA [1]   (NA)
Month 12 (n=96, 96, 94, 44, 44, NA) 4.6  (0.57) 4.7  (0.57) 3.7  (0.58) 2.9  (0.82) 4.3  (0.82) NA [1]   (NA)
[1]
Results were not reported for this group.
40.Secondary Outcome
Title Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)
Hide Description BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.
Time Frame From Baseline to Months 1, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score>0 cm and were evaluable. n=number of participants evaluable at each visit.
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Overall Number of Participants Analyzed 24 21 10 10 12 22
Least Squares Mean (Standard Error)
Unit of Measure: cm
Month 1 (n=24, 21, 10, NA, NA, 22) -1.23  (0.537) -1.60  (0.508) -2.30  (0.673) NA [1]   (NA) NA [1]   (NA) -1.27  (0.581)
Month 3 (n=24, 21, 10, NA, NA, 22) -1.83  (0.579) -2.78  (0.559) -2.93  (0.753) NA [1]   (NA) NA [1]   (NA) -1.60  (0.624)
Month 6 (n=23, 21, 10, 9, 11, NA) -2.24  (0.580) -2.35  (0.560) -3.58  (0.758) -2.85  (0.778) -3.31  (0.744) NA [1]   (NA)
Month 9 (n=23, 20, 10, 9, 9, NA) -2.06  (0.575) -2.71  (0.558) 2.66  (0.747) -3.00  (0.770) -3.35  (0.761) NA [1]   (NA)
Month 12 (n=23, 19, 10, 9, 9, NA) -2.50  (0.594) -3.30  (0.587) -2.42  (0.779) -2.31  (0.808) -2.67  (0.806) NA [1]   (NA)
[1]
Results were not reported for this group.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Hide Arm/Group Description Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks. Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
All-Cause Mortality
Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/107 (7.48%)   4/104 (3.85%)   9/106 (8.49%)   3/52 (5.77%)   4/53 (7.55%) 
Cardiac disorders           
Atrial fibrillation  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Bradycardia  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Cardiac arrest  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  1/52 (1.92%)  0/53 (0.00%) 
Gastrointestinal disorders           
Abdominal hernia  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Chronic gastritis  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Diverticulum  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Nausea  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Hepatobiliary disorders           
Bile duct stone  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Infections and infestations           
Appendicitis  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  1/52 (1.92%)  0/53 (0.00%) 
Herpes simplex  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Influenza  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Pneumonia  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  1/52 (1.92%)  0/53 (0.00%) 
Pyoderma streptococcal  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Injury, poisoning and procedural complications           
Joint injury  1  1/107 (0.93%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Musculoskeletal and connective tissue disorders           
Intervertebral disc disorder  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Musculoskeletal chest pain  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Psoriatic arthropathy  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Spondylolisthesis  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bladder transitional cell carcinoma  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Infected neoplasm  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Invasive ductal breast carcinoma  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Squamous cell carcinoma of the vulva  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Nervous system disorders           
Migraine  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Transient ischaemic attack  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Renal and urinary disorders           
Calculus urinary  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Nephropathy  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Reproductive system and breast disorders           
Cystocele  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Postmenopausal haemorrhage  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Rectocele  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Uterine polyp  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Respiratory, thoracic and mediastinal disorders           
Bronchial hyperreactivity  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Bronchospasm  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Dyspnoea exertional  1  0/107 (0.00%)  0/104 (0.00%)  1/106 (0.94%)  0/52 (0.00%)  0/53 (0.00%) 
Hypoxia  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Skin and subcutaneous tissue disorders           
Angioedema  1  1/107 (0.93%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Dermal cyst  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  0/107 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Hypertension  1  0/107 (0.00%)  1/104 (0.96%)  0/106 (0.00%)  0/52 (0.00%)  0/53 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, Version 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tofacitinib, 5 mg, Twice Daily Tofacitinib, 10 mg, Twice Daily Adalimumab, 40 mg, Every 2 Weeks Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/107 (28.97%)   43/104 (41.35%)   43/106 (40.57%)   15/52 (28.85%)   22/53 (41.51%) 
Gastrointestinal disorders           
Abdominal pain  1  1/107 (0.93%)  1/104 (0.96%)  2/106 (1.89%)  0/52 (0.00%)  3/53 (5.66%) 
Nausea  1  3/107 (2.80%)  4/104 (3.85%)  6/106 (5.66%)  0/52 (0.00%)  1/53 (1.89%) 
Infections and infestations           
Nasopharyngitis  1  8/107 (7.48%)  12/104 (11.54%)  11/106 (10.38%)  4/52 (7.69%)  4/53 (7.55%) 
Pharyngitis  1  5/107 (4.67%)  6/104 (5.77%)  7/106 (6.60%)  0/52 (0.00%)  3/53 (5.66%) 
Upper respiratory tract infection  1  10/107 (9.35%)  11/104 (10.58%)  8/106 (7.55%)  5/52 (9.62%)  5/53 (9.43%) 
Urinary tract infection  1  2/107 (1.87%)  4/104 (3.85%)  4/106 (3.77%)  1/52 (1.92%)  4/53 (7.55%) 
Investigations           
Alanine aminotransferase increased  1  3/107 (2.80%)  3/104 (2.88%)  8/106 (7.55%)  3/52 (5.77%)  1/53 (1.89%) 
Aspartate aminotransferase increased  1  0/107 (0.00%)  1/104 (0.96%)  7/106 (6.60%)  1/52 (1.92%)  1/53 (1.89%) 
Blood creatine phosphokinase increased  1  5/107 (4.67%)  5/104 (4.81%)  3/106 (2.83%)  1/52 (1.92%)  5/53 (9.43%) 
Musculoskeletal and connective tissue disorders           
Spinal pain  1  2/107 (1.87%)  1/104 (0.96%)  3/106 (2.83%)  3/52 (5.77%)  0/53 (0.00%) 
Nervous system disorders           
Headache  1  5/107 (4.67%)  11/104 (10.58%)  7/106 (6.60%)  2/52 (3.85%)  4/53 (7.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, Version 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01877668     History of Changes
Other Study ID Numbers: A3921091
2011-003668-55 ( EudraCT Number )
First Submitted: June 12, 2013
First Posted: June 14, 2013
Results First Submitted: December 4, 2016
Results First Posted: July 6, 2017
Last Update Posted: July 6, 2017