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Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors (OPAL BEYOND)

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: NCT01882439
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Tofacitinib
Other: Placebo
Enrollment 395
Recruitment Details Data through End of Study (Month 6)
Pre-assignment Details Of 546 participants screened for entry into the study, 395 were enrolled and randomized, 394 received treatment.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Hide Arm/Group Description Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily. Participants received two 5 mg tofacitinib tablets, twice daily. Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily. Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.
Period Title: Overall Study
Started 131 [1] 132 [1] 66 [1] 65 [1]
Completed 122 111 56 56
Not Completed 9 21 10 9
Reason Not Completed
Adverse event related to study drug             3             8             1             2
Pregnancy             0             1             0             0
Protocol Violation             2             2             0             1
No longer willing to participate             1             4             2             3
Medication error with no associated AE             0             0             2             0
Insufficient clinical response             1             4             4             2
Adverse event unrelated to study drug             2             2             1             1
[1]
Received treatment
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Total
Hide Arm/Group Description Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily. Participants received two 5 mg tofacitinib tablets, twice daily. Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily. Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily. Total of all reporting groups
Overall Number of Baseline Participants 131 132 66 65 394
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 132 participants 66 participants 65 participants 394 participants
49.5  (12.3) 51.3  (10.9) 48.7  (11.2) 49.3  (14.0) 50.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 132 participants 66 participants 65 participants 394 participants
Female
64
  48.9%
74
  56.1%
38
  57.6%
42
  64.6%
218
  55.3%
Male
67
  51.1%
58
  43.9%
28
  42.4%
23
  35.4%
176
  44.7%
1.Primary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3
Hide Description ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-reactive protein (CRP).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 131 132 131
Measure Type: Number
Unit of Measure: Percentage of participants
49.62 46.97 23.66
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 5 mg Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Large sample approximation
Comments Missing response (MR) = non-response (NR)
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 25.95
Confidence Interval (2-Sided) 95%
14.72 to 37.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 10 mg, Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Large sample approximation
Comments MR=NR
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.31
Confidence Interval (2-Sided) 95%
12.10 to 34.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.71
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3
Hide Description The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 129 132 131
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.3920  (0.04544) -0.3540  (0.04579) -0.1391  (0.04573)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 5 mg Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments No imputation
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2529
Confidence Interval (2-Sided) 95%
-0.3792 to -0.1266
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06422
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib, 10 mg, Twice Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Mixed Models Analysis
Comments No imputation
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2150
Confidence Interval (2-Sided) 95%
-0.3419 to -0.0881
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06453
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6
Hide Description ACR50 was calculated as a ≥50% improvement from baseline in tender /painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.
Time Frame Week 2 and Months 1, 2, 3, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 131 132 66 65 131
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=8,13,NA,NA,4) 6.11 9.85 NA [1]  NA [1]  3.05
Month 1 (n=23,14,NA,NA,8) 17.56 10.61 NA [1]  NA [1]  6.11
Month 2 (n=33,30,NA,NA,14) 25.19 22.73 NA [1]  NA [1]  10.69
Month 3 (n=39,37,NA,NA,19) 29.77 28.03 NA [1]  NA [1]  14.50
Month 4 (n=50,38,15,21,NA) 38.17 28.79 22.73 32.31 NA [2] 
Month 6 (n=50,39,21,23,NA) 38.17 29.55 31.82 35.38 NA [2] 
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
4.Secondary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6
Hide Description ACR70 was calculated as a ≥70% improvement from baseline in tender /painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.
Time Frame Week 2 and Months 1, 2, 3, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily for 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 131 132 66 65 131
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=2,3,NA,NA,1) 1.53 2.27 NA [1]  NA [1]  0.76
Month 1 (n=7,5,NA,NA,3) 5.34 3.79 NA [1]  NA [1]  2.29
Month 2 (n=17,13,NA,NA,6) 12.98 9.85 NA [1]  NA [1]  4.58
Month 3 (n=22,19,NA,NA,13) 16.79 14.39 NA [1]  NA [1]  9.92
Month 4 (n=24,20,6,14,NA) 18.32 15.15 9.09 21.54 NA [2] 
Month 6 (n=28,19,10,12,NA) 21.37 14.39 15.15 18.46 NA [2] 
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
5.Secondary Outcome
Title Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6
Hide Description ACR20 was calculated as a ≥20% improvement from baseline in tender /painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.
Time Frame Week 2 and Months 1, 2, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 131 132 66 65 131
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=35,38,NA,NA,17) 26.72 28.79 NA [1]  NA [1]  12.98
Month 1 (n=45,56,NA,NA,29) 34.35 42.42 NA [1]  NA [1]  22.14
Month 2 (n=63,63,NA,NA,34) 48.09 47.73 NA [1]  NA [1]  25.95
Month 4 (n=78,69,30,33,NA) 59.54 52.27 45.45 50.77 NA [2] 
Month 6 (n=78,65,33,35,NA) 59.54 49.24 50.00 53.85 NA [2] 
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
6.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6
Hide Description The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. n=number of participants evaluable at each visit.
Time Frame Week 2 and Months 1, 2, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 129 132 66 65 131
Least Squares Mean (Standard Error)
Unit of Measure: Units on scale
Week 2 (129,130,NA,NA,128) -0.2198  (0.03145) -0.1652  (0.03160) NA [1]   (NA) NA [1]   (NA) -0.0655  (0.03133)
Month 1 (128,129,NA,NA,130) -0.3229  (0.04074) -0.2279  (0.04073) NA [1]   (NA) NA [1]   (NA) -0.1481  (0.04038)
Month 2 (125,126,NA,NA,121) -0.4114  (0.04311) -0.3131  (0.04316) NA [1]   (NA) NA [1]   (NA) -0.1620  (0.04317)
Month 4 (125,121,57,58,NA) -0.4455  (0.04489) -0.3305  (0.04523) -0.3836  (0.06443) -0.3918  (0.06418) NA [2]   (NA)
Month 6 (122,112,56,56,NA) -0.4365  (0.04642) -0.3397  (0.04720) -0.4808  (0.06680) -0.4157  (0.06665) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
7.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 130 132 131
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
-5.4657  (1.80096) -5.9156  (1.83181) 1.0233  (1.82879)
8.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3
Hide Description Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 129 132 131
Least Squares Mean (Standard Error)
Unit of Measure: mm
-21.66  (2.162) -20.88  (2.188) -7.72  (2.184)
9.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3
Hide Description Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 129 132 131
Least Squares Mean (Standard Error)
Unit of Measure: mm
-21.59  (2.228) -19.88  (2.248) -7.14  (2.247)
10.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3
Hide Description The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 128
Least Squares Mean (Standard Error)
Unit of Measure: mm
-27.25  (1.893) -28.95  (1.916) -15.88  (1.929)
11.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3
Hide Description Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 130 132 131
Least Squares Mean (Standard Error)
Unit of Measure: Joints
-7.6  (0.59) -6.7  (0.60) -2.7  (0.60)
12.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3
Hide Description Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 130 132 131
Least Squares Mean (Standard Error)
Unit of Measure: Joints
-9.9  (0.97) -9.7  (0.98) -4.5  (0.98)
13.Secondary Outcome
Title Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6
Hide Description The PsARC covers 4 measures: Tender joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. n=number of responders.
Time Frame Week 2, Months 1, 2, 3, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 131 132 66 65 131
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=43,45,NA,NA,23) 32.82 34.09 NA [1]  NA [1]  17.56
Month 1 (n=56,66,NA,NA,45) 42.75 50.00 NA [1]  NA [1]  34.35
Month 2 (n=67,72,NA,NA,43) 51.15 54.55 NA [1]  NA [1]  32.82
Month 3 (n=77,64,NA,NA,38) 58.78 48.48 NA [1]  NA [1]  29.01
Month 4 (n=74,75,34,38.NA) 56.49 56.82 51.52 58.46 NA [2] 
Month 6 (n=77,68,34,36,NA) 58.78 51.52 51.52 55.38 NA [2] 
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
14.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6
Hide Description The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine the PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). n=number of participants evaluable at each visit.
Time Frame Months 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO >0, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 121 124 63 62 125
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=120,122,NA,NA,125) -0.5  (0.07) -0.8  (0.07) NA [1]   (NA) NA [1]   (NA) -0.2  (0.07)
Month 3 (n=112,116,NA,NA,112) -0.7  (0.08) -1.1  (0.08) NA [1]   (NA) NA [1]   (NA) -0.4  (0.08)
Month 6 (n=116,108,55,51,NA) -0.9  (0.08) -1.1  (0.09) -1.0  (0.12) -1.0  (0.13) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
15.Secondary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6
Hide Description PASI determines psoriasis severity based on lesion severity and percentage of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, and scaling evaluated separately for the head and neck, upper limbs, trunk, and lower limbs and then rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis and is assigned a numerical score: 0=no involvement; 1=0% to 9%; 2=10% to 29%; 3=30% to 49%; 4=50% to 69%; 5=70% to 89%; 6=90% to 100%. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the 4 body areas is the PASI. PASI75 is defined as a 75% reduction from baseline in PASI. n=number of responders.
Time Frame Months 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug with PASI >0 and BSA ≥3% at baseline.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 80 81 42 44 86
Measure Type: Number
Unit of Measure: Percentage of participants
Month 1 (n=12,15,NA,NA,5) 15.00 18.52 NA [1]  NA [1]  5.81
Month 3 (n=17,35,NA,NA,12) 21.25 43.21 NA [1]  NA [1]  13.95
Month 6 (n=27,37,11,14,NA) 33.75 45.68 26.19 31.82 NA [2] 
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
16.Secondary Outcome
Title Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6
Hide Description Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline DSS >0, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 65 64 29 33 62
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=65,64,NA,NA,62) -2.8  (0.63) -4.0  (0.65) NA [1]   (NA) NA [1]   (NA) -1.1  (0.64)
Month 3 (n=64,58,NA,NA,55) -5.2  (0.73) -5.4  (0.78) NA [1]   (NA) NA [1]   (NA) -1.9  (0.78)
Month 6 (n=61,55,25,26,NA) -6.0  (0.84) -6.0  (0.90) -5.4  (1.33) -5.2  (1.26) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
17.Secondary Outcome
Title Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6
Hide Description The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score >0, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 95 105 47 51 98
Least Squares Mean (Standard Error)
Unit of Measure: Units of scale
Month 1 (n=94,104,NA,NA,98) -1.9  (0.31) -1.9  (0.30) NA [1]   (NA) NA [1]   (NA) -1.0  (0.30)
Month 3 (n=92,96,NA,NA,87) -2.5  (0.34) -2.8  (0.33) NA [1]   (NA) NA [1]   (NA) -1.3  (0.34)
Month 6 (n=91,93,40,43,NA) -2.6  (0.36) -3.1  (0.35) -2.6  (0.53) -2.4  (0.51) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
18.Secondary Outcome
Title Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6
Hide Description Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for a total score of 0-6. Higher score indicates greater severity of enthesitis. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with baseline LEI >0, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 82 96 45 46 91
Least Squares Mean (Standard Error)
Unit of Measure: Units of scale
Month 1 (n=82,95,NA,NA,91) -1.0  (0.19) -0.8  (0.18) NA [1]   (NA) NA [1]   (NA) -0.5  (0.18)
Month 3 (n=79,86,NA,NA,82) -1.3  (0.19) -1.3  (0.18) NA [1]   (NA) NA [1]   (NA) -0.5  (0.19)
Month 6 (n=77,84,38,41,NA) -1.5  (0.19) -1.6  (0.18) -1.4  (0.26) -1.3  (0.26) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
19.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 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 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 T-scores for both the SF36 version 2 and SF36 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. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 124 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=124,127,NA,NA,129) 4.65  (0.543) 3.98  (0.542) NA [1]   (NA) NA [1]   (NA) 1.70  (0.534)
Month 3 (n=121,120,NA,NA,117) 5.18  (0.684) 5.34  (0.687) NA [1]   (NA) NA [1]   (NA) 1.77  (0.689)
Month 6 (n=118,110,56,56,NA) 5.71  (0.751) 5.00  (0.768) 6.45  (1.076) 6.98  (1.074) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
20.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 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 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 T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better mental health status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 124 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=124,127,NA,NA,129) 4.09  (0.740) 4.19  (0.738) NA [1]   (NA) NA [1]   (NA) 2.33  (0.725)
Month 3 (n=121,120,NA,NA,117) 4.94  (0.875) 4.28  (0.879) NA [1]   (NA) NA [1]   (NA) 2.97  (0.880)
Month 6 (n=118,110,56,56,NA) 5.36  (0.878) 5.37  (0.902) 5.37  (1.265) 6.47  (1.259) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
21.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 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, & mental health. The 10 items of the physical functioning scale represent levels & kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher physical functioning domain score represents better physical functioning. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=128,129,NA,NA,129) 3.97  (0.583) 3.10  (0.587) NA [1]   (NA) NA [1]   (NA) 1.55  (0.580)
Month 3 (n=124,120,NA,NA,117) 5.00  (0.721) 4.08  (0.732) NA [1]   (NA) NA [1]   (NA) 1.69  (0.734)
Month 6 (n=121,112,56,56,NA) 5.39  (0.795) 3.88  (0.818) 5.89  (1.153) 5.60  (1.149) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
22.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 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, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-physical domain score represents better role-physical functioning. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 126 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=126,128,NA,NA,129) 4.22  (0.630) 3.55  (0.633) NA [1]   (NA) NA [1]   (NA) 2.24  (0.623)
Month 3 (n=122,120,NA,NA,117) 4.99  (0.805) 5.44  (0.814) NA [1]   (NA) NA [1]   (NA) 2.85  (0.814)
Month 6 (n=120,112,56,56,NA) 5.58  (0.857) 5.24  (0.881) 7.01  (1.241) 7.21  (1.239) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
23.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher bodily pain domain score represents less bodily pain. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 127 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=127,128,NA,NA,129) 6.86  (0.634) 6.39  (0.638) NA [1]   (NA) NA [1]   (NA) 2.31  (0.633)
Month 3 (n=124,120,NA,NA,117) 7.00  (0.786) 7.59  (0.799) NA [1]   (NA) NA [1]   (NA) 2.10  (0.804)
Month 6 (n=121,112,56,56,NA) 7.60  (0.848) 7.69  (0.876) 8.15  (1.234) 10.48  (1.236) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
24.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher general health domain score represents better general health perceptions. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=128,128,NA,NA,129) 3.24  (0.529) 3.74  (0.535) NA [1]   (NA) NA [1]   (NA) 2.29  (0.527)
Month 3 (n=124,120,NA,NA,117) 3.67  (0.639) 3.92  (0.651) NA [1]   (NA) NA [1]   (NA) 2.45  (0.651)
Month 6 (n=121,111,56,56,NA) 3.88  (0.695) 4.46  (0.719) 6.00  (1.010) 5.34  (1.010) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
25.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher vitality domain score represents better vitality. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=128,128,NA,NA,129) 4.52  (0.678) 4.30  (0.684) NA [1]   (NA) NA [1]   (NA) 1.73  (0.674)
Month 3 (n=124,120,NA,NA,117) 4.95  (0.828) 4.75  (0.842) NA [1]   (NA) NA [1]   (NA) 2.41  (0.843)
Month 6 (n=122,111,56,56,NA) 5.94  (0.859) 5.15  (0.894) 5.75  (1.256) 7.06  (1.256) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
26.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher social functioning domain score represents better social functioning. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=128,129,NA,NA,129) 4.93  (0.748) 4.92  (0.754) NA [1]   (NA) NA [1]   (NA) 2.33  (0.744)
Month 3 (n=124,120,NA,NA,117) 6.25  (0.844) 5.46  (0.861) NA [1]   (NA) NA [1]   (NA) 2.89  (0.861)
Month 6 (n=122,112,56,56,NA) 5.92  (0.896) 5.58  (0.930) 5.96  (1.309) 7.90  (1.305) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
27.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-emotional domain score represents better role-emotional functioning. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 125 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=125,128,NA,NA,129) 4.44  (0.894) 3.64  (0.892) NA [1]   (NA) NA [1]   (NA) 3.25  (0.878)
Month 3 (n=121,120,NA,NA,117) 5.44  (0.998) 4.84  (1.003) NA [1]   (NA) NA [1]   (NA) 3.85  (1.002)
Month 6 (n=119,111,56,56,NA) 6.17  (1.010) 5.69  (1.040) 7.05  (1.461) 8.00  (1.455) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
28.Secondary Outcome
Title Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 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 T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher mental health domain score represents better mental health functioning. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Month 1 (n=128,128,NA,NA,129) 3.80  (0.737) 4.41  (0.743) NA [1]   (NA) NA [1]   (NA) 1.73  (0.732)
Month 3 (n=124,120,NA,NA,117) 4.36  (0.852) 4.11  (0.867) NA [1]   (NA) NA [1]   (NA) 2.11  (0.868)
Month 6 (n=122,112,56,56,NA) 4.38  (0.854) 4.98  (0.884) 5.06  (1.245) 5.67  (1.241) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
29.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=128,128,NA,NA,129) -0.15  (0.035) -0.10  (0.036) NA [1]   (NA) NA [1]   (NA) -0.08  (0.035)
Month 3 (n=124,120,NA,NA,117) -0.17  (0.038) -0.15  (0.039) NA [1]   (NA) NA [1]   (NA) -0.05  (0.039)
Month 6 (n=122,112,56,55,NA) -0.15  (0.040) -0.15  (0.042) -0.23  (0.059) -0.32  (0.059) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
30.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 127 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=127,128,NA,NA,129) -0.11  (0.039) -0.14  (0.039) NA [1]   (NA) NA [1]   (NA) -0.03  (0.038)
Month 3 (n=122,120,NA,NA,117) -0.15  (0.039) -0.15  (0.040) NA [1]   (NA) NA [1]   (NA) -0.04  (0.039)
Month 6 (n=120,112,56,55,NA) -0.19  (0.040) -0.15  (0.042) -0.19  (0.058) -0.17  (0.059) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
31.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=128,128,NA,NA,129) -0.22  (0.039) -0.19  (0.039) NA [1]   (NA) NA [1]   (NA) -0.17  (0.039)
Month 3 (n=124,120,NA,NA,117) -0.23  (0.042) -0.22  (0.042) NA [1]   (NA) NA [1]   (NA) -0.15  (0.043)
Month 6 (n=122,112,56,55,NA) -0.30  (0.047) -0.25  (0.048) -0.39  (0.068) -0.34  (0.068) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
32.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=128,128,NA,NA,129) -0.26  (0.038) -0.25  (0.039) NA [1]   (NA) NA [1]   (NA) -0.11  (0.038)
Month 3 (n=124,120,NA,NA,117) -0.32  (0.043) -0.29  (0.044) NA [1]   (NA) NA [1]   (NA) -0.12  (0.044)
Month 6 (n=121,112,56,55,NA) -0.34  (0.045) -0.31  (0.047) -0.42  (0.066) -0.34  (0.067) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
33.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=128,128,NA,NA,129) -0.13  (0.043) -0.21  (0.043) NA [1]   (NA) NA [1]   (NA) -0.10  (0.042)
Month 3 (n=124,120,NA,NA,117) -0.19  (0.044) -0.20  (0.045) NA [1]   (NA) NA [1]   (NA) -0.12  (0.045)
Month 6 (n=122,112,56,55,NA) -0.16  (0.046) -0.20  (0.048) -0.17  (0.068) -0.31  (0.068) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
34.Secondary Outcome
Title Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6
Hide Description The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: mm
Month 1 (n=127,128,NA,NA,128) 9.76  (1.565) 9.58  (1.574) NA [1]   (NA) NA [1]   (NA) 3.59  (1.557)
Month 3 (n=124,119,NA,NA,117) 8.62  (1.853) 12.33  (1.896) NA [1]   (NA) NA [1]   (NA) 2.64  (1.896)
Month 6 (n=122,112,56,55,NA) 12.14  (1.870) 12.63  (1.945) 15.68  (2.736) 15.32  (2.748) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
35.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6
Hide Description FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=128,129,NA,NA,129) 6.0  (0.66) 4.4  (0.67) NA [1]   (NA) NA [1]   (NA) 2.2  (0.66)
Month 3 (n=124,120,NA,NA,117) 7.0  (0.81) 5.8  (0.82) NA [1]   (NA) NA [1]   (NA) 3.0  (0.82)
Month 6 (n=122,113,56,56,NA) 7.1  (0.87) 6.2  (0.90) 7.6  (1.28) 8.5  (1.28) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
36.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6
Hide Description FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=128,129,NA,NA,129) 2.7  (0.31) 2.3  (0.31) NA [1]   (NA) NA [1]   (NA) 1.0  (0.30)
Month 3 (n=124,120,NA,NA,117) 3.1  (0.38) 2.6  (0.39) NA [1]   (NA) NA [1]   (NA) 1.5  (0.39)
Month 6 (n=122,113,56,56,NA) 2.9  (0.40) 2.8  (0.41) 3.2  (0.58) 4.1  (0.58) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
37.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6
Hide Description FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 128 130 64 65 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Month 1 (n=128,129,NA,NA,129) 3.3  (0.40) 2.1  (0.41) NA [1]   (NA) NA [1]   (NA) 1.2  (0.40)
Month 3 (n=124,120,NA,NA,117) 3.9  (0.48) 3.2  (0.49) NA [1]   (NA) NA [1]   (NA) 1.6  (0.49)
Month 6 (n=122,113,56,56,NA) 4.2  (0.52) 3.5  (0.54) 4.3  (0.76) 4.5  (0.76) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
38.Secondary Outcome
Title Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6
Hide Description BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participants answered 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averaged the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. n=number of participants evaluable at each visit.
Time Frame Months 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score >0 cm, and were evaluable.
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily Placebo
Hide Arm/Group Description:
Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
Participants received two placebo tablets twice daily up to 3 months.
Overall Number of Participants Analyzed 26 25 10 12 22
Least Squares Mean (Standard Error)
Unit of Measure: cm
Month 1 (n=26,25,NA,NA,22) -2.04  (0.400) -1.26  (0.412) NA [1]   (NA) NA [1]   (NA) -0.34  (0.415)
Month 3 (n=26,22,NA,NA,19) -2.26  (0.465) -1.92  (0.490) NA [1]   (NA) NA [1]   (NA) -1.00  (0.506)
Month 6 (n=25,22,8,10,NA) -2.02  (0.463) -1.56  (0.489) -2.26  (0.756) -3.05  (0.701) NA [2]   (NA)
[1]
Results for this group are reported under the 'Placebo' treatment arm since participants received only placebo up to 3 months.
[2]
Results for this group are reported under the 'Placebo/Tofacitinib, 5 or 10 mg, twice daily' treatment arms since participants did not receive placebo beyond 3 months.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Hide Arm/Group Description Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily. Participants received two 5 mg tofacitinib tablets twice daily. Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily. Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
All-Cause Mortality
Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/131 (3.82%)   8/132 (6.06%)   2/66 (3.03%)   1/65 (1.54%) 
Cardiac disorders         
Acute myocardial infarction † 1  1/131 (0.76%)  0/132 (0.00%)  0/66 (0.00%)  0/65 (0.00%) 
Angina pectoris † 1  1/131 (0.76%)  0/132 (0.00%)  0/66 (0.00%)  0/65 (0.00%) 
Atrial flutter † 1  0/131 (0.00%)  0/132 (0.00%)  1/66 (1.52%)  0/65 (0.00%) 
Endocrine disorders         
Hyperthyroidism † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Gastrointestinal disorders         
Inguinal hernia † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Infections and infestations         
Oral candidiasis † 1  1/131 (0.76%)  0/132 (0.00%)  0/66 (0.00%)  0/65 (0.00%) 
Parotitis † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Pneumonia † 1  1/131 (0.76%)  0/132 (0.00%)  0/66 (0.00%)  0/65 (0.00%) 
Pyelonephritis † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Tibia fracture † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Metabolism and nutrition disorders         
Dehydration † 1  1/131 (0.76%)  0/132 (0.00%)  0/66 (0.00%)  0/65 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle haemorrhage † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Nervous system disorders         
Cerebrovascular accident † 1  0/131 (0.00%)  1/132 (0.76%)  0/66 (0.00%)  0/65 (0.00%) 
Syncope † 1  0/131 (0.00%)  0/132 (0.00%)  0/66 (0.00%)  1/65 (1.54%) 
Respiratory, thoracic and mediastinal disorders         
Asthma † 1  0/131 (0.00%)  0/132 (0.00%)  1/66 (1.52%)  0/65 (0.00%) 
Vascular disorders         
Hypertensive crisis † 1  0/131 (0.00%)  0/132 (0.00%)  1/66 (1.52%)  0/65 (0.00%) 
Hypotension † 1  1/131 (0.76%)  0/132 (0.00%)  0/66 (0.00%)  0/65 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tofacitinib, 5 mg Twice Daily Tofacitinib, 10 mg, Twice Daily Placebo/Tofacitinib, 5 mg, Twice Daily Placebo/Tofacitinib, 10 mg, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/131 (37.40%)   48/132 (36.36%)   19/66 (28.79%)   19/65 (29.23%) 
Gastrointestinal disorders         
Diarrhoea † 1  10/131 (7.63%)  8/132 (6.06%)  2/66 (3.03%)  2/65 (3.08%) 
Nausea † 1  5/131 (3.82%)  7/132 (5.30%)  5/66 (7.58%)  4/65 (6.15%) 
Infections and infestations         
Bronchitis † 1  3/131 (2.29%)  7/132 (5.30%)  1/66 (1.52%)  2/65 (3.08%) 
Nasopharyngitis † 1  14/131 (10.69%)  12/132 (9.09%)  4/66 (6.06%)  1/65 (1.54%) 
Sinusitis † 1  3/131 (2.29%)  5/132 (3.79%)  4/66 (6.06%)  2/65 (3.08%) 
Upper respiratory tract infection † 1  12/131 (9.16%)  7/132 (5.30%)  4/66 (6.06%)  7/65 (10.77%) 
Nervous system disorders         
Dizziness † 1  7/131 (5.34%)  1/132 (0.76%)  0/66 (0.00%)  1/65 (1.54%) 
Headache † 1  10/131 (7.63%)  12/132 (9.09%)  3/66 (4.55%)  4/65 (6.15%) 
Vascular disorders         
Hypertension † 1  8/131 (6.11%)  5/132 (3.79%)  2/66 (3.03%)  2/65 (3.08%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 19.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01882439    
Other Study ID Numbers: A3921125
2013-001368-46 ( EudraCT Number )
First Submitted: June 18, 2013
First Posted: June 20, 2013
Results First Submitted: February 17, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017