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An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate (ORAL STRATEGY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187055
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rhematoid Arthritis
Interventions Drug: Tofacitinib with methotrexate
Drug: Tofacitinib without methotrexate
Biological: Adalimumab with methotrexate
Enrollment 1152
Recruitment Details  
Pre-assignment Details Although a total of 1,152 participants were randomized, only 1,146 participants received treatment and are included in the full analysis set summarized below.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months. One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months. One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Period Title: Overall Study
Started 384 [1] 376 [1] 386 [1]
Completed 315 303 312
Not Completed 69 73 74
Reason Not Completed
Lack of Efficacy             10             3             7
Lost to Follow-up             2             7             3
No longer meets eligibility criteria             0             2             0
No longer willing to participate             6             8             10
Other             5             6             3
Protocol Violation             9             9             4
Pregnancy             3             1             0
Withdrawal by Subject             11             11             11
Adverse Event             21             26             36
Death             2             0             0
[1]
Treated
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX Total
Hide Arm/Group Description One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months. One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months. One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. Total of all reporting groups
Overall Number of Baseline Participants 384 376 386 1146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 384 participants 376 participants 386 participants 1146 participants
49.7  (12.2) 50.0  (13.4) 50.7  (13.4) 50.1  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 384 participants 376 participants 386 participants 1146 participants
Female
319
  83.1%
311
  82.7%
320
  82.9%
950
  82.9%
Male
65
  16.9%
65
  17.3%
66
  17.1%
196
  17.1%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6
Hide Description ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab).
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 384 376 386
Measure Type: Number
Unit of Measure: Percentage of participants
38.28 46.01 43.78
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was a treatment difference larger than -13% at the population level
Statistical Test of Hypothesis P-Value 0.2101
Comments [Not Specified]
Method Normal approximation to proportions
Comments Multiplicity-adjusted
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -7.73
Confidence Interval (2-Sided) 98.34%
-16.29 to 0.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was a treatment difference larger than -13% at the population level
Statistical Test of Hypothesis P-Value 0.0512
Comments [Not Specified]
Method Normal approximation to proportions
Comments Multiplicity-adjusted
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -5.50
Confidence Interval (2-Sided) 98.34%
-13.98 to 2.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was a treatment difference larger than -13% at the population level
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Normal approximation to proportions
Comments Multiplicity adjusted
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 2.23
Confidence Interval (2-Sided) 98.34%
-6.40 to 10.86
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6
Hide Description SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 355 343 345
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-23.7  (0.62) -26.6  (0.62) -25.6  (0.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
1.23 to 4.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
0.33 to 3.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.51 to 0.68
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6
Hide Description CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 345 347
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-22.9  (0.61) -25.5  (0.61) -24.8  (0.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.08 to 4.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
0.40 to 3.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.24 to 0.86
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6
Hide Description DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 355 343 345
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-2.1  (0.07) -2.5  (0.07) -2.3  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.16 to 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.05 to 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.28 to 0.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6
Hide Description DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 349 342 343
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-2.1  (0.07) -2.4  (0.07) -2.4  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.15 to 0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.10 to 0.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.23 to 0.13
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6
Hide Description To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 358 346 355
Measure Type: Number
Unit of Measure: Percentage of participants
7.54 8.67 9.58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-4.99 to 2.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -1.78
Confidence Interval (2-Sided) 95%
-5.59 to 2.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-4.53 to 3.40
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving SDAI ≤3.3 at Month 6
Hide Description SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 345 348
Measure Type: Number
Unit of Measure: Percentage of participants
10.64 13.91 14.37
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -3.40
Confidence Interval (2-Sided) 95%
-7.95 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -3.06
Confidence Interval (2-Sided) 95%
-7.55 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-4.45 to 5.14
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving CDAI ≤2.8 at Month 6
Hide Description CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 358 347 350
Measure Type: Number
Unit of Measure: Percentage of participants
10.89 14.70 14.57
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -3.67
Confidence Interval (2-Sided) 95%
-8.29 to 0.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -3.06
Confidence Interval (2-Sided) 95%
-7.59 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
-4.24 to 5.47
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6
Hide Description DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 353 344 346
Measure Type: Number
Unit of Measure: Percentage of participants
11.33 12.79 13.58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-6.03 to 2.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -2.02
Confidence Interval (2-Sided) 95%
-6.51 to 2.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-5.11 to 4.18
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6
Hide Description DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 345 348
Measure Type: Number
Unit of Measure: Percentage of participants
22.69 32.75 30.17
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -9.49
Confidence Interval (2-Sided) 95%
-15.68 to -3.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value -6.89
Confidence Interval (2-Sided) 95%
-12.94 to -0.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in remission rate
Estimated Value 2.61
Confidence Interval (2-Sided) 95%
-3.86 to 9.07
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Achieving SDAI ≤11 at Month 6
Hide Description SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, >3.4 to 11 indicates low disease activity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 345 348
Measure Type: Number
Unit of Measure: Percentage of participants
46.78 53.33 51.15
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -6.24
Confidence Interval (2-Sided) 95%
-13.32 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -3.66
Confidence Interval (2-Sided) 95%
-10.69 to 3.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 2.58
Confidence Interval (2-Sided) 95%
-4.51 to 9.68
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Achieving CDAI ≤10 at Month 6
Hide Description CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 358 347 350
Measure Type: Number
Unit of Measure: Percentage of participants
45.53 52.45 50.00
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -6.22
Confidence Interval (2-Sided) 95%
-13.29 to 0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -3.93
Confidence Interval (2-Sided) 95%
-10.94 to 3.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 2.30
Confidence Interval (2-Sided) 95%
-4.79 to 9.39
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6
Hide Description DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 353 344 346
Measure Type: Number
Unit of Measure: Percentage of participants
22.10 28.49 29.77
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -6.02
Confidence Interval (2-Sided) 95%
-12.05 to 0.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -6.89
Confidence Interval (2-Sided) 95%
-12.90 to -0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-7.17 to 5.44
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6
Hide Description DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 345 348
Measure Type: Number
Unit of Measure: Percentage of participants
44.54 49.57 50.86
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -4.87
Confidence Interval (2-Sided) 95%
-11.92 to 2.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -5.48
Confidence Interval (2-Sided) 95%
-12.49 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in rresponse rate
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-7.70 to 6.47
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6
Hide Description ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 354 345 349
Measure Type: Number
Unit of Measure: Percentage of participants
70.06 79.13 77.65
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -8.29
Confidence Interval (2-Sided) 95%
-14.84 to -1.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -6.14
Confidence Interval (2-Sided) 95%
-12.72 to 0.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
-4.22 to 8.52
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6
Hide Description ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 343 349
Measure Type: Number
Unit of Measure: Percentage of participants
19.66 27.11 22.64
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -6.77
Confidence Interval (2-Sided) 95%
-12.61 to -0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -2.50
Confidence Interval (2-Sided) 95%
-8.09 to 3.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 4.27
Confidence Interval (2-Sided) 95%
-1.68 to 10.23
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6
Hide Description The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 348 350
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.52  (0.031) -0.58  (0.031) -0.54  (0.031)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.011 to 0.148
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.054 to 0.105
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.122 to 0.037
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6
Hide Description The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 348 350
Measure Type: Number
Unit of Measure: Percentage of participants
71.07 75.57 72.86
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -4.07
Confidence Interval (2-Sided) 95%
-10.68 to 2.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-7.87 to 5.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 2.86
Confidence Interval (2-Sided) 95%
-3.72 to 9.43
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6
Hide Description The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 355 346 349
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
6.7  (0.44) 7.9  (0.43) 7.8  (0.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.28 to -0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.16 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.97 to 1.20
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6
Hide Description The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 355 346 349
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
5.2  (0.52) 5.7  (0.51) 4.4  (0.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.74 to 0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-0.48 to 2.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-0.04 to 2.56
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6
Hide Description SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 348 349
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
6.4  (0.52) 7.3  (0.52) 7.3  (0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.22 to 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.19 to 0.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.27 to 1.34
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6
Hide Description SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 347 350
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
6.7  (0.47) 7.0  (0.47) 6.3  (0.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.52 to 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.80 to 1.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.47 to 1.91
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 348 350
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
8.2  (0.48) 10.3  (0.48) 9.9  (0.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-3.25 to -0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.91 to -0.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.89 to 1.55
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 347 350
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
5.1  (0.44) 6.3  (0.44) 5.4  (0.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.27 to -0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.40 to 0.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-0.25 to 1.98
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 348 350
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
5.6  (0.48) 6.1  (0.47) 5.7  (0.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.71 to 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.33 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.83 to 1.57
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 348 350
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
6.3  (0.52) 7.2  (0.52) 6.2  (0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.20 to 0.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-1.13 to 1.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-0.26 to 2.39
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 347 350
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
6.7  (0.58) 7.7  (0.58) 6.0  (0.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.54 to 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.76 to 2.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
0.30 to 3.24
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6
Hide Description The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 356 348 350
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
5.3  (0.52) 5.5  (0.52) 5.0  (0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.55 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.01 to 1.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.78 to 1.86
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6
Hide Description The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 341 343
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of impairment
Work hours missed due to problems -2.62  (0.717) -2.19  (0.700) -1.75  (0.741)
Work hours missed other reason 0.14  (1.019) 0.43  (0.991) -0.77  (1.059)
Hours worked in past 7 days 4.13  (1.729) -0.82  (1.672) 1.28  (1.788)
Problems affecting productivity -1.94  (0.228) -2.14  (0.224) -1.95  (0.232)
Problem affecting daily activities -2.24  (0.137) -2.47  (0.138) -2.24  (0.139)
% work time missed due to health -4.51  (1.790) -3.41  (1.794) -1.87  (1.831)
% impairment while working due to health -19.38  (2.276) -21.44  (2.235) -19.52  (2.320)
% overall work impairment due to health -20.16  (2.663) -22.27  (2.638) -21.87  (2.710)
% activity impairment due to health -22.36  (1.375) -24.74  (1.383) -22.45  (1.394)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Work hours missed due to problems
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-2.279 to 1.427
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Work hours missed due to problems
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-2.783 to 1.044
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Work hours missed due to problems
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-2.349 to 1.462
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Work hours missed other reason
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-2.928 to 2.346
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Work hours missed other reason
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
-1.832 to 3.640
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Work hours missed other reason
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
-1.520 to 3.911
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Hours worked in past 7 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.95
Confidence Interval (2-Sided) 95%
0.520 to 9.370
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Hours worked in past 7 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.85
Confidence Interval (2-Sided) 90%
-1.736 to 7.430
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Hours worked in past 7 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-6.650 to 2.454
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Problems affecting productivity
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.373 to 0.786
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Problems affecting productivity
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.578 to 0.607
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Problems affecting productivity
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.784 to 0.400
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Problem affecting daily activities
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.112 to 0.587
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Problem affecting daily activities
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.341 to 0.357
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Problem affecting daily activities
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.582 to 0.122
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments % work time missed due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-5.748 to 3.553
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments % work time missed due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.64
Confidence Interval (2-Sided) 95%
-7.339 to 2.067
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments % work time missed due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-6.283 to 3.207
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments % impairment while working due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.07
Confidence Interval (2-Sided) 95%
-3.726 to 7.858
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments % impairment while working due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-5.777 to 6.068
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments % impairment while working due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.92
Confidence Interval (2-Sided) 95%
-7.839 to 3.998
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments % overall work impairment due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.11
Confidence Interval (2-Sided) 95%
-4.664 to 8.877
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments % overall work impairment due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
-5.164 to 8.580
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments % overall work impairment due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-7.307 to 6.510
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments % activity impairment due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.38
Confidence Interval (2-Sided) 95%
-1.118 to 5.873
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments % activity impairment due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-3.411 to 3.573
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments % activity impairment due to health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.30
Confidence Interval (2-Sided) 95%
-5.818 to 1.225
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6
Hide Description The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 5 mg BID + MTX Adalimumab 40 mg + MTX
Hide Arm/Group Description:
One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
Overall Number of Participants Analyzed 357 348 351
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Utility score 0.20  (0.013) 0.22  (0.013) 0.22  (0.013)
Mobility score -0.29  (0.027) -0.26  (0.027) -0.28  (0.027)
Self-care score -0.27  (0.028) -0.33  (0.028) -0.32  (0.028)
Usual activities score -0.24  (0.029) -0.26  (0.029) -0.30  (0.029)
Pain/discomfort score -0.32  (0.026) -0.34  (0.026) -0.37  (0.026)
Anxiety/depression score -0.21  (0.029) -0.24  (0.029) -0.22  (0.029)
VAS score 20.84  (1.100) 20.98  (1.100) 19.61  (1.100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Utility score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.057 to 0.011
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Utility score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.054 to 0.013
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Utility score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.031 to 0.036
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Mobility score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.098 to 0.042
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Mobility score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.079 to 0.060
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Mobility score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.051 to 0.089
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Self-care score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.014 to 0.127
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Self-care score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.027 to 0.114
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Self-care score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.083 to 0.058
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Usual activities score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.062 to 0.084
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Usual activities score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.018 to 0.129
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID + MTX, Adalimumab 40 mg + MTX
Comments Usual activities score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.029 to 0.118
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Tofacitinib 5 mg BID + MTX
Comments Pain/discomfort score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.041 to 0.091
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Adalimumab 40 mg + MTX
Comments Pain/discomfort score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.015 to 0.116
Estimation Comments [Not Specified]