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A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02281552
Recruitment Status : Completed
First Posted : November 2, 2014
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: Tofacitinib
Enrollment 209
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description Participants orally received 11 milligrams (mg) of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks. Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Period Title: Overall Study
Started 104 105
Completed 100 95
Not Completed 4 10
Reason Not Completed
Medication error             1             0
Insufficient clinical response             0             1
Adverse Event             3             9
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR) Total
Hide Arm/Group Description Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks. Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 104 105 209
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 105 participants 209 participants
57.1  (11.4) 58.9  (10.2) 58  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 105 participants 209 participants
Female
86
  82.7%
75
  71.4%
161
  77.0%
Male
18
  17.3%
30
  28.6%
48
  23.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 105 participants 209 participants
Asian
104
 100.0%
105
 100.0%
209
 100.0%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12
Hide Description DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, CRP (milligrams per liter [mg/L]) and patient global assessment of disease activity on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) [less than or equal to] <= 3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) less than (<) 2.6 implied remission.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 100 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.43  (0.09) -2.85  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib Modified Release (MR), Tofacitinib Immediate Release (IR)
Comments Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of tofacitinib MR 11 mg QD to IR 5 mg BID was concluded if the upper bound of the 2-sided 95% confidence interval of differences between the treatment groups (MR 11 mg QD - IR 5 mg BID) at Week 12 was less than the pre-specified non-inferiority margin of 0.6.
Method of Estimation Estimation Parameter Least Square (LS) mean difference
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.17 to 0.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12
Hide Description DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hr]) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 99 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.50  (0.09) -2.86  (0.09)
3.Secondary Outcome
Title Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12
Hide Description Participants with 20% improvement in 68-tender and 66-swollen joint counts and 20% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using non-responder imputation (NRI) method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
87 83
4.Secondary Outcome
Title Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
Hide Description Participants with 50% improvement in 68-tender and 66-swollen joint counts and 50% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
70 71
5.Secondary Outcome
Title Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12
Hide Description Participants with 70% improvement in 68-tender and 66-swollen joint counts and 70% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
32 48
6.Secondary Outcome
Title Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12
Hide Description DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. Number of participants with DAS remission (DAS28-4-CRP<2.6) were reported in this outcome measure.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
52 72
7.Secondary Outcome
Title Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12
Hide Description DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. Number of participants with DAS remission (DAS28-4-ESR<2.6) were reported in this outcome measure.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
18 36
8.Secondary Outcome
Title Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12
Hide Description DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. Number of participants with low disease activity (DAS28-4-CRP<=3.2) were reported in this outcome measure.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
76 82
9.Secondary Outcome
Title Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12
Hide Description DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. Number of participants with low disease activity (DAS28-4-ESR<=3.2) were reported in this outcome measure.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
44 63
10.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Hide Description HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 99 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.44  (0.04) -0.46  (0.04)
11.Secondary Outcome
Title Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12
Hide Description HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. Number of participants with an improvement of at least 0.22 units in HAQ scores from baseline to Week 12 were reported in this outcome measure.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
65 60
12.Secondary Outcome
Title Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12
Hide Description SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores (physical component scores [PCS], mental component scores [MCS]) ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 99 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Functioning 5.54  (0.67) 6.29  (0.68)
Role Physical 6.51  (0.81) 6.97  (0.83)
Bodily Pain 9.41  (0.77) 11.92  (0.78)
General Health 4.53  (0.52) 4.72  (0.53)
Vitality 8.07  (0.75) 8.20  (0.76)
Social Function 4.26  (0.63) 5.06  (0.64)
Role Emotional 7.23  (0.86) 6.56  (0.87)
Mental Health 4.46  (0.80) 5.26  (0.81)
13.Secondary Outcome
Title Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12
Hide Description SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 99 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
PCS 6.59  (0.58) 7.85  (0.59)
MCS 5.29  (0.76) 5.08  (0.77)
14.Secondary Outcome
Title Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12
Hide Description The FACIT-Fatigue Scale was a participant completed questionnaire consisted of 13 items that assessed fatigue. Each item was scored on a scale of 0 (not at all) to 4 (very much), Total score ranging from 0 (not at all) to 52 (very much), higher scores represented lower level of fatigue.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 99 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.28  (0.66) 6.12  (0.67)
15.Secondary Outcome
Title Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12
Hide Description EQ-5D was a participant completed instrument designed to assess impact on quality of life in terms of a single utility score in five domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional systems are converted into a single index utility score between 0 and 1, where higher score indicated a better health state.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 99 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.20  (0.02) 0.25  (0.02)
16.Other Pre-specified Outcome
Title Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to 12 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non- serious adverse events.
Time Frame Baseline up to 12 weeks
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Hide Analysis Population Description
Safety analysis set included all participants who were randomized and received at least one dose of the randomized investigational drug.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 104 105
Measure Type: Number
Unit of Measure: participants
AEs 55 54
SAEs 5 4
17.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Laboratory Test Abnormalities
Hide Description Criteria: lipids(cholesterol[CH] milligrams/deciliter[mg/dL] >1.3*upper limit normal(ULN), high-density lipoprotein CH mg/dL <0.8*lower limit normal(LLN), Low-density lipoprotein CH mg/dL >1.2* ULN, triglycerides mg/dL >1.3*ULN); neutrophil count(NC) <1000 cells/cubic milliliters(mm^3), platelet counts(PC) <100,000 P/mm^3, lymphocyte counts(LC) <500 L/mm^3, any single (aspartate transaminase elevation(ASTE)/alanine transaminase elevation(ALTE) >=3*ULN, hemoglobin(Hb) value <8.0 grams(g)/dL or >=2 g/dL below baseline, any serum creatinine(SC) increase(inc) >50% or inc >0.5 mg/dL over the average of screening(OAS) and baseline values(BV), 2 sequential ASTE/ALTE>=3*ULN with total bilirubin value(TBV) >=2*ULN, ASTE/ALTE >=3*ULN, ASTE/ALTE >=5*ULN, Hb <8.0 g/dL or decrease of >30% from BV, PC <75,000 P/mm^3, NC <1000 cells/mm^3, LC <500 L/mm^3, confirmed inc in SC >50% OAS and BV and detection of hepatitis B virus-deoxyribonucleic acid(HBV-DNA) by the two sequential quantitative tests.
Time Frame Baseline up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were randomized and received at least one dose of the randomized investigational drug.
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description:
Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
Overall Number of Participants Analyzed 104 105
Measure Type: Number
Unit of Measure: participants
Cholesterol 11 8
High-density lipoprotein Cholesterol 1 1
Low-density lipoprotein Cholesterol 22 21
Triglycerides 6 10
Neutrophil counts <1000 cells/mm3 0 0
Platelet counts <100,000 platelets/mm3 0 0
Lymphocyte counts <500 lymphocytes/mm3 1 0
Any single AST and/or ALT elevation >=3xULN 1 0
Any single Hb value <8.0 g/dL or >=2 gm/dL 0 2
Any serum creatinine increase >50% 0 0
2sequential AST/ALT elevations>=3xULN, TBV>=2xULN 0 0
2 sequential AST or ALT elevations >=3xULN 1 0
2 sequential AST or ALT elevations >=5xULN 0 0
2sequential Hb<8.0 g/dL or decrease of >30%from BV 0 1
2 sequential platelet counts <75,000 platelets/mm3 0 0
2 sequential neutrophil counts <1000 cells/mm3 0 0
2 sequential lymphocyte count <500 lymphocytes/mm3 0 0
Confirmed increases in serum creatinine >50% 0 0
Detection of HBV-DNA 0 0
Time Frame From baseline up to 12 weeks
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all participants who received at least one dose of the study drug.
 
Arm/Group Title Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Hide Arm/Group Description Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks. Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
All-Cause Mortality
Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)   0/105 (0.00%) 
Hide Serious Adverse Events
Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/104 (4.81%)   4/105 (3.81%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/104 (0.00%)  1/105 (0.95%) 
Infections and infestations     
Pneumocystis jirovecii pneumonia * 1  2/104 (1.92%)  1/105 (0.95%) 
Pneumonia * 1  1/104 (0.96%)  1/105 (0.95%) 
Pneumonia bacterial * 1  0/104 (0.00%)  1/105 (0.95%) 
Injury, poisoning and procedural complications     
Femoral neck fracture * 1  1/104 (0.96%)  0/105 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal cancer * 1  1/104 (0.96%)  0/105 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease * 1  0/104 (0.00%)  1/105 (0.95%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tofacitinib Modified Release (MR) Tofacitinib Immediate Release (IR)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/104 (9.62%)   13/105 (12.38%) 
Infections and infestations     
Nasopharyngitis * 1  10/104 (9.62%)  13/105 (12.38%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
[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 than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02281552    
Other Study ID Numbers: A3921215
TOFACITINIB QD P3 ( Other Identifier: Alias Study Number )
First Submitted: October 30, 2014
First Posted: November 2, 2014
Results First Submitted: March 12, 2018
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018