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Efficacy Study Of Tofacitinib In Pediatric JIA Population

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ClinicalTrials.gov Identifier: NCT02592434
Recruitment Status : Completed
First Posted : October 30, 2015
Results First Posted : February 21, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Juvenile Idiopathic Arthritis
Interventions Drug: CP-690,550 (tofacitinib)
Other: placebo
Enrollment 225
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tofacitinib: Open-Label Phase Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase. Participants who completed open-label phase and achieved at least a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44). Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Period Title: Open-Label Phase (18 Weeks)
Started 225 0 0
Treated 225 0 0
Completed 185 0 0
Not Completed 40 0 0
Reason Not Completed
Adverse Event             12             0             0
Insufficient Clinical Response             21             0             0
Other             3             0             0
Protocol Deviation             4             0             0
Period Title: Double Blind Phase (26 Weeks)
Started 0 88 [1] 85 [2]
Treated 0 88 85
Completed 0 61 38
Not Completed 0 27 47
Reason Not Completed
Adverse Event             0             2             2
Insufficient Clinical Response             0             22             44
Other             0             1             0
Protocol Deviation             0             0             1
Medication error without associated AEs             0             1             0
Withdrawal By Parent/Guardian             0             1             0
[1]
Only those participants who completed OL phase, achieved at least a JIA ACR 30 response in OL phase.
[2]
Only those participants who completed OL phase,achieved at least a JIA ACR 30 response in OL phase.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Baseline Participants 225
Hide Baseline Analysis Population Description
The open-label phase full analysis set (OLFAS) consisted of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean Number Analyzed 225 participants
11.92  (4.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants
Female
169
  75.1%
Male
56
  24.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants
Hispanic or Latino
64
  28.4%
Not Hispanic or Latino
161
  71.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   2.2%
White
196
  87.1%
More than one race
0
   0.0%
Unknown or Not Reported
24
  10.7%
1.Primary Outcome
Title Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44
Hide Description According to PRCSG/PRINTO, disease flare defined as worsening of >=30 percent(%) in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables: 1) Number of joints with active arthritis (joint with swelling/in absence of swelling, limited range of motion accompanied by pain/tenderness), 2)Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a Visual Analog Scale[VAS] of 0[no activity] to 10[maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0[very well] to 10[very poor], 5) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI): 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score,which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) Erythrocyte Sedimentation Rate(ESR).
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The Double Blind polyarticular course JIA analysis set (DBJAS) included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
29.17 52.86
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments Threshold for significance at 0.05 level.
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -23.69
Confidence Interval (2-Sided) 95%
-39.41 to -7.97
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44
Hide Description JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
66.67 47.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0166
Comments Threshold for significance at 0.05 level.
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 19.52
Confidence Interval (2-Sided) 95%
3.55 to 35.50
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44
Hide Description JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
70.83 47.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments Threshold for significance at 0.05 level.
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.69
Confidence Interval (2-Sided) 95%
7.97 to 39.41
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44
Hide Description JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
54.17 37.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0387
Comments Threshold for significance at 0.05 level.
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.02
Confidence Interval (2-Sided) 95%
0.88 to 33.17
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44
Hide Description CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Week 44 in DI total score is reported.
Time Frame Baseline, Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 49 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.09  (0.04) 0.03  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance. Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0292
Comments Threshold for significance at 0.05 level.
Method Mixed Model for Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Ls mean difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.22 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 2, 4, 8, 12 and 18
Hide Description According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, ‘number analyzed’ (n) signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 184 participants
0.54
Week 4 Number Analyzed 183 participants
3.83
Week 8 Number Analyzed 175 participants
5.14
Week 12 Number Analyzed 166 participants
7.23
Week 18 Number Analyzed 154 participants
8.44
7.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Disease Flare According to PRCSG/PRINTO Disease Flare Criteria at Week 20, 24, 28, 32, 36 and 40
Hide Description According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Weeks 20, 24, 28, 32, 36 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Week 20 9.72 11.43
Week 24 12.50 31.43
Week 28 18.06 37.14
Week 32 23.61 45.71
Week 36 25.00 48.57
Week 40 27.78 52.86
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7410
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-11.82 to 8.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -18.93
Confidence Interval (2-Sided) 95%
-32.22 to -5.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0093
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -19.09
Confidence Interval (2-Sided) 95%
-33.48 to -4.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0045
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -22.10
Confidence Interval (2-Sided) 95%
-37.35 to -6.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -23.57
Confidence Interval (2-Sided) 95%
-38.97 to -8.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -25.08
Confidence Interval (2-Sided) 95%
-40.69 to -9.47
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Open-Label Phase: Time to Disease Flare
Hide Description Time to disease flare:time (in days) from first dose of study drug until the day of disease flare in open-label phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Day 1 up to week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
Median, upper and lower limits of 95% CI was not estimable due to small number of participants with the event.
9.Secondary Outcome
Title Double Blind Phase: Time to Disease Flare
Hide Description Time to disease flare: time (in days) from first dose of study drug until the day of disease flare in double blind phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Day 1 of Week 19 up to week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
155.0 [2] 
(86.0 to NA)
[1]
Median, upper and lower limits of 95% CI was not estimable due to small number of participants with the event.
[2]
Upper limit of 95% CI was not estimable due to small number of participants with the event.
10.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Weeks 2, 4, 8, 12 and 18
Hide Description JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 184 participants
45.11
Week 4 Number Analyzed 183 participants
68.31
Week 8 Number Analyzed 177 participants
79.66
Week 12 Number Analyzed 167 participants
85.63
Week 18 Number Analyzed 154 participants
92.21
11.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40
Hide Description JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 100.00 100.00
Week 20 88.89 82.86
Week 24 86.11 68.57
Week 28 80.56 61.43
Week 32 76.39 52.86
Week 36 73.61 48.57
Week 40 70.83 47.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3010
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.03
Confidence Interval (2-Sided) 95%
-5.40 to 17.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0108
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.54
Confidence Interval (2-Sided) 95%
4.05 to 31.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 19.13
Confidence Interval (2-Sided) 95%
4.51 to 33.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.53
Confidence Interval (2-Sided) 95%
8.27 to 38.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 25.04
Confidence Interval (2-Sided) 95%
9.52 to 40.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments at Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.69
Confidence Interval (2-Sided) 95%
7.97 to 39.41
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Weeks 2, 4, 8, 12 and 18
Hide Description JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 184 participants
20.11
Week 4 Number Analyzed 183 participants
44.81
Week 8 Number Analyzed 177 participants
62.71
Week 12 Number Analyzed 167 participants
71.86
Week 18 Number Analyzed 154 participants
83.77
13.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40
Hide Description JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 90.28 91.43
Week 20 81.94 74.29
Week 24 80.56 58.57
Week 28 73.61 55.71
Week 32 69.44 44.29
Week 36 68.06 47.14
Week 40 68.06 45.71
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Double Blind Baseline (Week 18)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8119
Comments [Not Specified]
Method Normal approximation for binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-10.63 to 8.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2682
Comments [Not Specified]
Method Normal approximation for binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.66
Confidence Interval (2-Sided) 95%
-5.90 to 21.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Normal approximation for binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 21.98
Confidence Interval (2-Sided) 95%
7.26 to 36.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0233
Comments [Not Specified]
Method Normal approximation for binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.90
Confidence Interval (2-Sided) 95%
2.44 to 33.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Normal approximation for binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 25.16
Confidence Interval (2-Sided) 95%
9.39 to 40.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0099
Comments [Not Specified]
Method Normal approximation for binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 20.91
Confidence Interval (2-Sided) 95%
5.01 to 36.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method Normal approximation for binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 22.34
Confidence Interval (2-Sided) 95%
6.46 to 38.22
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Weeks 2, 4, 8, 12 and 18
Hide Description JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 184 participants
7.61
Week 4 Number Analyzed 183 participants
16.94
Week 8 Number Analyzed 177 participants
36.16
Week 12 Number Analyzed 167 participants
46.71
Week 18 Number Analyzed 154 participants
61.04
15.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Double Blind Baseline (Week 18),Week 20, 24, 28, 32, 36 and 40
Hide Description JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 68.06 64.29
Week 20 58.33 55.71
Week 24 58.33 44.29
Week 28 54.17 47.14
Week 32 56.94 38.57
Week 36 54.17 34.29
Week 40 54.17 34.29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Double Blind Baseline (Week 18)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6348
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.77
Confidence Interval (2-Sided) 95%
-11.79 to 19.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7525
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.62
Confidence Interval (2-Sided) 95%
-13.66 to 18.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0908
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 14.05
Confidence Interval (2-Sided) 95%
-2.23 to 30.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4026
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.02
Confidence Interval (2-Sided) 95%
-9.38 to 23.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0258
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 18.37
Confidence Interval (2-Sided) 95%
2.22 to 34.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 19.88
Confidence Interval (2-Sided) 95%
3.88 to 35.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 19.88
Confidence Interval (2-Sided) 95%
3.88 to 35.88
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Week 2, 4, 8, 12 and 18
Hide Description JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 184 participants
0
Week 4 Number Analyzed 183 participants
3.83
Week 8 Number Analyzed 177 participants
11.30
Week 12 Number Analyzed 167 participants
20.96
Week 18 Number Analyzed 154 participants
33.12
17.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Hide Description JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 33.33 38.57
Week 20 34.72 25.71
Week 24 37.50 28.57
Week 28 36.11 27.14
Week 32 38.89 22.86
Week 36 38.89 20.00
Week 40 34.72 22.86
Week 44 34.72 21.43
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Double Blind Baseline (Week 18)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5150
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -5.24
Confidence Interval (2-Sided) 95%
-21.00 to 10.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2400
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.01
Confidence Interval 95%
-6.02 to 24.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2557
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 8.93
Confidence Interval (2-Sided) 95%
-6.47 to 24.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2481
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 8.97
Confidence Interval (2-Sided) 95%
-6.25 to 24.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0356
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 16.03
Confidence Interval (2-Sided) 95%
1.08 to 30.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 18.89
Confidence Interval (2-Sided) 95%
4.24 to 33.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1150
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.87
Confidence Interval (2-Sided) 95%
-2.89 to 26.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 44
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0744
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 13.29
Confidence Interval (2-Sided) 95%
-1.31 to 27.90
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Week 2, 4, 8, 12 and 18
Hide Description JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 184 participants
0.0
Week 4 Number Analyzed 183 participants
2.19
Week 8 Number Analyzed 177 participants
8.47
Week 12 Number Analyzed 167 participants
14.37
Week 18 Number Analyzed 154 participants
21.43
19.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Hide Description JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
Time Frame Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 15.28 31.43
Week 20 27.78 17.14
Week 24 27.78 24.29
Week 28 26.39 24.29
Week 32 27.78 21.43
Week 36 30.56 18.57
Week 40 29.17 20.00
Week 44 29.17 17.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Double Blind Baseline (Week 18)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0207
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -16.15
Confidence Interval (2-Sided) 95%
-29.84 to -2.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1254
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.63
Confidence Interval (2-Sided) 95%
-2.97 to 24.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6350
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.49
Confidence Interval (2-Sided) 95%
-10.93 to 17.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7732
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.10
Confidence Interval (2-Sided) 95%
-12.20 to 16.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3782
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.35
Confidence Interval (2-Sided) 95%
-7.77 to 20.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0936
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.98
Confidence Interval (2-Sided) 95%
-2.02 to 25.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2017
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.17
Confidence Interval (2-Sided) 95%
-4.91 to 23.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 44
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0858
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.02
Confidence Interval (2-Sided) 95%
-1.69 to 25.74
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Open Label Phase: Change From Baseline in Juvenile Arthritis Disease Activity Score 27 (JADAS-27) C-Reactive Protein (CRP) Score at Weeks 2, 4, 8, 12 and 18
Hide Description JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Baseline, Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: score on scale
Week 2 Number Analyzed 181 participants
-6.35  (5.44)
Week 4 Number Analyzed 180 participants
-9.89  (6.54)
Week 8 Number Analyzed 175 participants
-12.47  (7.51)
Week 12 Number Analyzed 163 participants
-14.33  (6.96)
Week 18 Number Analyzed 153 participants
-15.80  (7.12)
21.Secondary Outcome
Title Double Blind Phase: Change From Double-Blind Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27 C-Reactive Protein (CRP) Score at Week 20, 24, 28, 32, 36, 40 and 44
Hide Description JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in mg/L and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 20 Number Analyzed 70 participants 69 participants
0.27  (0.64) 2.33  (0.64)
Week 24 Number Analyzed 65 participants 59 participants
0.83  (0.95) 4.46  (0.97)
Week 28 Number Analyzed 63 participants 47 participants
0.51  (0.91) 4.36  (0.97)
Week 32 Number Analyzed 59 participants 43 participants
0.16  (0.73) 3.46  (0.81)
Week 36 Number Analyzed 54 participants 36 participants
0.34  (1.09) 6.55  (1.22)
Week 40 Number Analyzed 53 participants 34 participants
0.85  (1.13) 7.11  (1.26)
Week 44 Number Analyzed 49 participants 32 participants
0.03  (0.91) 4.39  (1.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20; Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0088
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.07
Confidence Interval (2-Sided) 95%
-3.60 to -0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0054
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.64
Confidence Interval (2-Sided) 95%
-6.17 to -1.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.85
Confidence Interval (2-Sided) 95%
-6.38 to -1.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.30
Confidence Interval (2-Sided) 95%
-5.30 to -1.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.21
Confidence Interval (2-Sided) 95%
-9.42 to -3.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.26
Confidence Interval (2-Sided) 95%
-9.60 to -2.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.36
Confidence Interval (2-Sided) 95%
-7.02 to -1.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.27
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18
Hide Description JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Baseline, weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: score on scale
Week 2 Number Analyzed 180 participants
-6.38  (5.52)
Week 4 Number Analyzed 180 participants
-10.14  (6.63)
Week 8 Number Analyzed 174 participants
-12.60  (7.60)
Week 12 Number Analyzed 165 participants
-14.54  (6.90)
Week 18 Number Analyzed 154 participants
-15.94  (7.17)
23.Secondary Outcome
Title Double Blind Phase: Change From Double-Blind Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Description JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 20 Number Analyzed 71 participants 70 participants
0.62  (0.62) 2.45  (0.62)
Week 24 Number Analyzed 66 participants 60 participants
0.92  (0.90) 4.33  (0.92)
Week 28 Number Analyzed 63 participants 49 participants
0.64  (0.86) 4.22  (0.90)
Week 32 Number Analyzed 59 participants 45 participants
0.26  (0.75) 3.67  (0.81)
Week 36 Number Analyzed 55 participants 37 participants
0.60  (1.06) 6.26  (1.17)
Week 40 Number Analyzed 53 participants 35 participants
0.73  (1.05) 6.35  (1.15)
Week 44 Number Analyzed 49 participants 33 participants
0.09  (0.91) 4.50  (0.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20: Analysis was based on Mixed Model for Repeated Measures (MMRM) with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.83
Confidence Interval (2-Sided) 95%
-3.32 to -0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0057
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.41
Confidence Interval (2-Sided) 95%
-5.81 to -1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.58
Confidence Interval (2-Sided) 95%
-5.94 to -1.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.41
Confidence Interval (2-Sided) 95%
-5.47 to -1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.66
Confidence Interval (2-Sided) 95%
-8.74 to -2.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.62
Confidence Interval (2-Sided) 95%
-8.66 to -2.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 44:Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.41
Confidence Interval (2-Sided) 95%
-6.99 to -1.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.25
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18
Hide Description Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(maximum of 27 defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 184 participants
0
Week 2 Number Analyzed 183 participants
2.19
Week 4 Number Analyzed 183 participants
9.29
Week 8 Number Analyzed 176 participants
20.45
Week 12 Number Analyzed 165 participants
29.09
Week 18 Number Analyzed 154 participants
44.16
25.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Hide Description Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 48.61 47.14
Week 20 45.83 35.71
Week 24 47.22 34.29
Week 28 47.22 35.71
Week 32 40.28 32.86
Week 36 44.44 30.00
Week 40 45.83 31.43
Week 44 47.22 32.86
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Double Blind Baseline (Week 18)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8610
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
-14.96 to 17.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2173
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.12
Confidence Interval (2-Sided) 95%
-5.96 to 26.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1135
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.94
Confidence Interval (2-Sided) 95%
-3.08 to 28.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1610
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.51
Confidence Interval (2-Sided) 95%
-4.58 to 27.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3571
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.42
Confidence Interval (2-Sided) 95%
-8.37 to 23.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0716
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 14.44
Confidence Interval (2-Sided) 95%
-1.27 to 30.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0746
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 14.40
Confidence Interval (2-Sided) 95%
-1.43 to 30.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 44
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0773
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 14.37
Confidence Interval (2-Sided) 95%
-1.57 to 30.30
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18
Hide Description JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 183 participants
0
Week 4 Number Analyzed 183 participants
0
Week 8 Number Analyzed 176 participants
2.84
Week 12 Number Analyzed 165 participants
3.64
Week 18 Number Analyzed 154 participants
7.79
27.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Hide Description JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 6.94 10.00
Week 20 9.72 2.86
Week 24 12.50 5.71
Week 28 9.72 7.14
Week 32 11.11 5.71
Week 36 16.67 7.14
Week 40 18.06 7.14
Week 44 18.06 10.00
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Double Blind Baseline (Week 18)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5131
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -3.06
Confidence Interval (2-Sided) 95%
-12.21 to 6.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0876
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.87
Confidence Interval (2-Sided) 95%
-1.01 to 14.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1561
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.79
Confidence Interval (2-Sided) 95%
-2.59 to 16.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5795
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.58
Confidence Interval (2-Sided) 95%
-6.54 to 11.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2435
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 5.40
Confidence Interval (2-Sided) 95%
-3.67 to 14.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0758
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.52
Confidence Interval (2-Sided) 95%
-0.99 to 20.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0464
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.91
Confidence Interval (2-Sided) 95%
0.17 to 21.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 44
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1634
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 8.06
Confidence Interval (2-Sided) 95%
-3.27 to 19.38
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With JIA ACR Inactive Disease at Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Description JIA ACR Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the Standardized Uveitis Nomenclature (SUN) Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of "0") on the scale used, morning stiffness of <=15 minutes.
Time Frame Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
Double Blind Baseline (Week 18) 9.72 27.14
Week 20 15.28 15.71
Week 24 20.83 21.43
Week 28 19.44 18.57
Week 32 22.22 20.00
Week 36 26.39 17.14
Week 40 26.39 14.29
Week 44 26.39 17.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Double Blind baseline (Week 18)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -17.42
Confidence Interval (2-Sided) 95%
-29.88 to -4.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9427
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-12.34 to 11.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9308
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-14.03 to 12.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8945
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
-12.03 to 13.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7455
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
-11.20 to 15.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1787
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.25
Confidence Interval (2-Sided) 95%
-4.23 to 22.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0695
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.10
Confidence Interval (2-Sided) 95%
-0.97 to 25.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 44
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1787
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.25
Confidence Interval (2-Sided) 95%
-4.23 to 22.72
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Double Blind Phase: Percentage of Participants With Presence of JIA ACR Clinical Remission
Hide Description JIA ACR Clinical Remission Criteria included: Clinical inactive disease for 6 months continuously while on medications for JIA. Clinical Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the SUN Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of "0") on the scale used, morning stiffness of less than or equal to (<=) 15 minutes.
Time Frame From Week 18 in double blind phase up to Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Measure Type: Number
Unit of Measure: percentage of participants
4.17 4.29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9719
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-6.74 to 6.50
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Active Arthritis at Week 2, 4, 8, 12 and 18
Hide Description Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. The score range of the number of joints is from 0-71.
Time Frame Baseline, Weeks 2, 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Open-Label Phase
Hide Arm/Group Description:
Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: joints with active arthritis
Week 2 Number Analyzed 183 participants
-4.54  (5.33)
Week 4 Number Analyzed 181 participants
-7.21  (6.36)
Week 8 Number Analyzed 175 participants
-8.62  (7.04)
Week 12 Number Analyzed 166 participants
-9.76  (6.76)
Week 18 Number Analyzed 154 participants
-10.29  (6.79)
31.Secondary Outcome
Title Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Active Arthritis at Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Description Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. Number of joints ranged from 0 to 71.
Time Frame Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Hide Outcome Measure Data
Hide Analysis Population Description
The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tofacitinib: Double Blind Phase Placebo
Hide Arm/Group Description:
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
Overall Number of Participants Analyzed 72 70
Least Squares Mean (Standard Error)
Unit of Measure: joints with active arthritis
Week 20 Number Analyzed 71 participants 70 participants
0.21  (0.48) 1.07  (0.49)
Week 24 Number Analyzed 66 participants 60 participants
0.69  (0.71) 2.11  (0.72)
Week 28 Number Analyzed 63 participants 50 participants
0.46  (0.61) 2.13  (0.64)
Week 32 Number Analyzed 59 participants 45 participants
0.19  (0.48) 1.36  (0.51)
Week 36 Number Analyzed 55 participants 37 participants
0.52  (0.85) 4.50  (0.92)
Week 40 Number Analyzed 53 participants 35 participants
0.91  (0.85) 4.48  (0.93)
Week 44 Number Analyzed 49 participants 33 participants
0.55  (0.74) 2.79  (0.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib: Double Blind Phase, Placebo
Comments Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1595
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-2.08 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.61
Estimation C