Trial Outcomes & Findings for Efficacy Study Of Tofacitinib In Pediatric JIA Population (NCT NCT02592434)

Last Updated: 2020-04-13

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

225 participants

Primary outcome timeframe

Week 44

Results posted on

2020-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Tofacitinib: Open-Label Phase 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.	Tofacitinib: Double Blind 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).	Placebo 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).
Open-Label Phase (18 Weeks) STARTED	225	0	0
Open-Label Phase (18 Weeks) Treated	225	0	0
Open-Label Phase (18 Weeks) COMPLETED	185	0	0
Open-Label Phase (18 Weeks) NOT COMPLETED	40	0	0
Double Blind Phase (26 Weeks) STARTED	0	88	85
Double Blind Phase (26 Weeks) Treated	0	88	85
Double Blind Phase (26 Weeks) COMPLETED	0	61	38
Double Blind Phase (26 Weeks) NOT COMPLETED	0	27	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib: Open-Label Phase 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.	Tofacitinib: Double Blind 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).	Placebo 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).
Open-Label Phase (18 Weeks) Adverse Event	12	0	0
Open-Label Phase (18 Weeks) Insufficient Clinical Response	21	0	0
Open-Label Phase (18 Weeks) Other	3	0	0
Open-Label Phase (18 Weeks) Protocol Deviation	4	0	0
Double Blind Phase (26 Weeks) Adverse Event	0	2	2
Double Blind Phase (26 Weeks) Insufficient Clinical Response	0	22	44
Double Blind Phase (26 Weeks) Other	0	1	0
Double Blind Phase (26 Weeks) Protocol Deviation	0	0	1
Double Blind Phase (26 Weeks) Medication error without associated AEs	0	1	0
Double Blind Phase (26 Weeks) Withdrawal By Parent/Guardian	0	1	0

Baseline Characteristics

Efficacy Study Of Tofacitinib In Pediatric JIA Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib: Open-Label Phase n=225 Participants 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.
Age, Continuous Mean	11.92 Years STANDARD_DEVIATION 4.06 • n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	161 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	196 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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	29.17 percentage of participants	52.86 percentage of participants

SECONDARY outcome

Timeframe: Week 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44	66.67 percentage of participants	47.14 percentage of participants

SECONDARY outcome

Timeframe: Week 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44	70.83 percentage of participants	47.14 percentage of participants

SECONDARY outcome

Timeframe: Week 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44	54.17 percentage of participants	37.14 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=49 Participants 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).	Placebo n=33 Participants 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).
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	-0.09 units on a scale Standard Error 0.04	0.03 units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 2	0.54 percentage of participants	—
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 Week 4	3.83 percentage of participants	—
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 Week 8	5.14 percentage of participants	—
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 Week 12	7.23 percentage of participants	—
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 Week 18	8.44 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 20, 24, 28, 32, 36 and 40

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 20	9.72 percentage of participants	11.43 percentage of participants
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 Week 24	12.50 percentage of participants	31.43 percentage of participants
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 Week 28	18.06 percentage of participants	37.14 percentage of participants
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 Week 32	23.61 percentage of participants	45.71 percentage of participants
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 Week 36	25.00 percentage of participants	48.57 percentage of participants
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 Week 40	27.78 percentage of participants	52.86 percentage of participants

SECONDARY outcome

Timeframe: Day 1 up to week 18

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open-Label Phase: Time to Disease Flare	NA days Median, upper and lower limits of 95% CI was not estimable due to small number of participants with the event.	—

SECONDARY outcome

Timeframe: Day 1 of Week 19 up to week 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: Time to Disease Flare	NA days Median, upper and lower limits of 95% CI was not estimable due to small number of participants with the event.	155.0 days Interval 86.0 to Upper limit of 95% CI was not estimable due to small number of participants with the event.

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 2	45.11 percentage of participants	—
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 Week 4	68.31 percentage of participants	—
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 Week 8	79.66 percentage of participants	—
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 Week 12	85.63 percentage of participants	—
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 Week 18	92.21 percentage of participants	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 24	86.11 percentage of participants	68.57 percentage of participants
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 Week 28	80.56 percentage of participants	61.43 percentage of participants
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 Week 32	76.39 percentage of participants	52.86 percentage of participants
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 Week 36	73.61 percentage of participants	48.57 percentage of participants
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 Week 40	70.83 percentage of participants	47.14 percentage of participants
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 Double Blind Baseline (Week 18)	100.00 percentage of participants	100.00 percentage of participants
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 Week 20	88.89 percentage of participants	82.86 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 2	20.11 percentage of participants	—
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 Week 4	44.81 percentage of participants	—
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 Week 8	62.71 percentage of participants	—
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 Week 12	71.86 percentage of participants	—
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 Week 18	83.77 percentage of participants	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 32	69.44 percentage of participants	44.29 percentage of participants
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 Double Blind Baseline (Week 18)	90.28 percentage of participants	91.43 percentage of participants
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 Week 20	81.94 percentage of participants	74.29 percentage of participants
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 Week 24	80.56 percentage of participants	58.57 percentage of participants
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 Week 28	73.61 percentage of participants	55.71 percentage of participants
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 Week 40	68.06 percentage of participants	45.71 percentage of participants
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 Week 36	68.06 percentage of participants	47.14 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 4	16.94 percentage of participants	—
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 Week 8	36.16 percentage of participants	—
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 Week 2	7.61 percentage of participants	—
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 Week 18	61.04 percentage of participants	—
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 Week 12	46.71 percentage of participants	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 36	54.17 percentage of participants	34.29 percentage of participants
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 Week 40	54.17 percentage of participants	34.29 percentage of participants
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 Double Blind Baseline (Week 18)	68.06 percentage of participants	64.29 percentage of participants
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 Week 20	58.33 percentage of participants	55.71 percentage of participants
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 Week 24	58.33 percentage of participants	44.29 percentage of participants
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 Week 28	54.17 percentage of participants	47.14 percentage of participants
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 Week 32	56.94 percentage of participants	38.57 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 2	0 percentage of participants	—
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 Week 4	3.83 percentage of participants	—
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 Week 8	11.30 percentage of participants	—
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 Week 12	20.96 percentage of participants	—
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 Week 18	33.12 percentage of participants	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Double Blind Baseline (Week 18)	33.33 percentage of participants	38.57 percentage of participants
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 Week 20	34.72 percentage of participants	25.71 percentage of participants
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 Week 24	37.50 percentage of participants	28.57 percentage of participants
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 Week 28	36.11 percentage of participants	27.14 percentage of participants
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 Week 32	38.89 percentage of participants	22.86 percentage of participants
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 Week 36	38.89 percentage of participants	20.00 percentage of participants
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 Week 40	34.72 percentage of participants	22.86 percentage of participants
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 Week 44	34.72 percentage of participants	21.43 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 2	0.0 percentage of participants	—
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 Week 4	2.19 percentage of participants	—
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 Week 8	8.47 percentage of participants	—
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 Week 12	14.37 percentage of participants	—
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 Week 18	21.43 percentage of participants	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 28	26.39 percentage of participants	24.29 percentage of participants
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 Double Blind Baseline (Week 18)	15.28 percentage of participants	31.43 percentage of participants
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 Week 20	27.78 percentage of participants	17.14 percentage of participants
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 Week 24	27.78 percentage of participants	24.29 percentage of participants
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 Week 32	27.78 percentage of participants	21.43 percentage of participants
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 Week 36	30.56 percentage of participants	18.57 percentage of participants
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 Week 40	29.17 percentage of participants	20.00 percentage of participants
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 Week 44	29.17 percentage of participants	17.14 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 2	-6.35 score on scale Standard Deviation 5.44	—
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 Week 12	-14.33 score on scale Standard Deviation 6.96	—
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 Week 18	-15.80 score on scale Standard Deviation 7.12	—
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 Week 4	-9.89 score on scale Standard Deviation 6.54	—
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 Week 8	-12.47 score on scale Standard Deviation 7.51	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 20	0.27 score on scale Standard Error 0.64	2.33 score on scale Standard Error 0.64
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 Week 24	0.83 score on scale Standard Error 0.95	4.46 score on scale Standard Error 0.97
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 Week 40	0.85 score on scale Standard Error 1.13	7.11 score on scale Standard Error 1.26
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 Week 44	0.03 score on scale Standard Error 0.91	4.39 score on scale Standard Error 1.00
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 Week 28	0.51 score on scale Standard Error 0.91	4.36 score on scale Standard Error 0.97
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 Week 32	0.16 score on scale Standard Error 0.73	3.46 score on scale Standard Error 0.81
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 Week 36	0.34 score on scale Standard Error 1.09	6.55 score on scale Standard Error 1.22

SECONDARY outcome

Timeframe: Baseline, weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18 Week 18	-15.94 score on scale Standard Deviation 7.17	—
Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18 Week 12	-14.54 score on scale Standard Deviation 6.90	—
Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18 Week 2	-6.38 score on scale Standard Deviation 5.52	—
Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18 Week 4	-10.14 score on scale Standard Deviation 6.63	—
Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18 Week 8	-12.60 score on scale Standard Deviation 7.60	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 20	0.62 score on scale Standard Error 0.62	2.45 score on scale Standard Error 0.62
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 Week 24	0.92 score on scale Standard Error 0.90	4.33 score on scale Standard Error 0.92
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 Week 28	0.64 score on scale Standard Error 0.86	4.22 score on scale Standard Error 0.90
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 Week 32	0.26 score on scale Standard Error 0.75	3.67 score on scale Standard Error 0.81
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 Week 36	0.60 score on scale Standard Error 1.06	6.26 score on scale Standard Error 1.17
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 Week 40	0.73 score on scale Standard Error 1.05	6.35 score on scale Standard Error 1.15
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 Week 44	0.09 score on scale Standard Error 0.91	4.50 score on scale Standard Error 0.97

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18 Baseline	0 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18 Week 4	9.29 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18 Week 8	20.45 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18 Week 18	44.16 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18 Week 2	2.19 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18 Week 12	29.09 percentage of participants	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 24	47.22 percentage of participants	34.29 percentage of participants
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 Week 32	40.28 percentage of participants	32.86 percentage of participants
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 Week 44	47.22 percentage of participants	32.86 percentage of participants
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 Double Blind Baseline (Week 18)	48.61 percentage of participants	47.14 percentage of participants
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 Week 20	45.83 percentage of participants	35.71 percentage of participants
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 Week 28	47.22 percentage of participants	35.71 percentage of participants
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 Week 36	44.44 percentage of participants	30.00 percentage of participants
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 Week 40	45.83 percentage of participants	31.43 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18 Week 12	3.64 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18 Week 2	0 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18 Week 4	0 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18 Week 8	2.84 percentage of participants	—
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18 Week 18	7.79 percentage of participants	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 24	12.50 percentage of participants	5.71 percentage of participants
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 Double Blind Baseline (Week 18)	6.94 percentage of participants	10.00 percentage of participants
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 Week 20	9.72 percentage of participants	2.86 percentage of participants
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 Week 28	9.72 percentage of participants	7.14 percentage of participants
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 Week 32	11.11 percentage of participants	5.71 percentage of participants
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 Week 36	16.67 percentage of participants	7.14 percentage of participants
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 Week 40	18.06 percentage of participants	7.14 percentage of participants
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 Week 44	18.06 percentage of participants	10.00 percentage of participants

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Double Blind Baseline (Week 18)	9.72 percentage of participants	27.14 percentage of participants
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 Week 20	15.28 percentage of participants	15.71 percentage of participants
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 Week 24	20.83 percentage of participants	21.43 percentage of participants
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 Week 36	26.39 percentage of participants	17.14 percentage of participants
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 Week 40	26.39 percentage of participants	14.29 percentage of participants
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 Week 28	19.44 percentage of participants	18.57 percentage of participants
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 Week 32	22.22 percentage of participants	20.00 percentage of participants
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 Week 44	26.39 percentage of participants	17.14 percentage of participants

SECONDARY outcome

Timeframe: From Week 18 in double blind phase up to Week 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: Percentage of Participants With Presence of JIA ACR Clinical Remission	4.17 percentage of participants	4.29 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
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 Week 2	-4.54 joints with active arthritis Standard Deviation 5.33	—
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 Week 4	-7.21 joints with active arthritis Standard Deviation 6.36	—
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 Week 8	-8.62 joints with active arthritis Standard Deviation 7.04	—
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 Week 12	-9.76 joints with active arthritis Standard Deviation 6.76	—
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 Week 18	-10.29 joints with active arthritis Standard Deviation 6.79	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
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 Week 32	0.19 joints with active arthritis Standard Error 0.48	1.36 joints with active arthritis Standard Error 0.51
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 Week 36	0.52 joints with active arthritis Standard Error 0.85	4.50 joints with active arthritis Standard Error 0.92
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 Week 40	0.91 joints with active arthritis Standard Error 0.85	4.48 joints with active arthritis Standard Error 0.93
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 Week 44	0.55 joints with active arthritis Standard Error 0.74	2.79 joints with active arthritis Standard Error 0.77
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 Week 20	0.21 joints with active arthritis Standard Error 0.48	1.07 joints with active arthritis Standard Error 0.49
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 Week 24	0.69 joints with active arthritis Standard Error 0.71	2.11 joints with active arthritis Standard Error 0.72
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 Week 28	0.46 joints with active arthritis Standard Error 0.61	2.13 joints with active arthritis Standard Error 0.64

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: 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.

The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18 Week 2	-2.52 joints with limited range of motion Standard Deviation 4.21	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18 Week 4	-3.56 joints with limited range of motion Standard Deviation 5.68	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18 Week 8	-4.53 joints with limited range of motion Standard Deviation 5.65	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18 Week 12	-5.09 joints with limited range of motion Standard Deviation 5.79	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18 Week 18	-5.77 joints with limited range of motion Standard Deviation 5.82	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44 Week 36	0.47 joints with limited range of motion Standard Error 0.31	1.48 joints with limited range of motion Standard Error 0.34
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44 Week 20	0.38 joints with limited range of motion Standard Error 0.20	0.64 joints with limited range of motion Standard Error 0.19
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44 Week 24	0.50 joints with limited range of motion Standard Error 0.28	1.19 joints with limited range of motion Standard Error 0.29
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44 Week 28	0.68 joints with limited range of motion Standard Error 0.35	1.63 joints with limited range of motion Standard Error 0.37
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44 Week 32	0.61 joints with limited range of motion Standard Error 0.32	1.40 joints with limited range of motion Standard Error 0.34
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44 Week 40	0.41 joints with limited range of motion Standard Error 0.34	1.49 joints with limited range of motion Standard Error 0.39
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44 Week 44	0.38 joints with limited range of motion Standard Error 0.29	1.20 joints with limited range of motion Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: 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.

Physician global evaluation of disease activity was measured on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'No Activity' and '10' as 'Maximum Activity', higher score indicated more disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18 Week 2	-1.81 score on scale Standard Deviation 1.52	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18 Week 4	-2.78 score on scale Standard Deviation 1.84	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18 Week 8	-3.51 score on scale Standard Deviation 1.83	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18 Week 12	-4.04 score on scale Standard Deviation 1.88	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18 Week 18	-4.54 score on scale Standard Deviation 1.92	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 24	0.24 score on scale Standard Error 0.24	1.08 score on scale Standard Error 0.24
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 28	0.12 score on scale Standard Error 0.21	0.92 score on scale Standard Error 0.92
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 36	0.14 score on scale Standard Error 0.28	1.56 score on scale Standard Error 0.32
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 20	0.28 score on scale Standard Error 0.20	0.82 score on scale Standard Error 0.20
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 32	-0.03 score on scale Standard Error 0.20	0.86 score on scale Standard Error 0.22
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 40	0.02 score on scale Standard Error 0.28	1.64 score on scale Standard Error 0.32
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 44	-0.16 score on scale Standard Error 0.29	1.42 score on scale Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: 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.

The parent/or legal guardian/participant rated the overall well-being on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'Very Well' and '10' as 'Very Poorly', higher scores=more disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18 Week 2	-0.94 score on scale Standard Deviation 1.95	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18 Week 4	-1.47 score on scale Standard Deviation 1.92	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18 Week 12	-2.30 score on scale Standard Deviation 2.15	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18 Week 18	-2.68 score on scale Standard Deviation 2.33	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18 Week 8	-1.90 score on scale Standard Deviation 2.20	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 20	-0.04 score on scale Standard Error 0.18	0.38 score on scale Standard Error 0.18
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 24	-0.03 score on scale Standard Error 0.22	0.91 score on scale Standard Error 0.22
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 36	-0.22 score on scale Standard Error 0.21	0.31 score on scale Standard Error 0.24
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 44	-0.49 score on scale Standard Error 0.22	0.24 score on scale Standard Error 0.24
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 28	-0.11 score on scale Standard Error 0.24	0.72 score on scale Standard Error 0.26
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 32	-0.15 score on scale Standard Error 0.24	0.82 score on scale Standard Error 0.26
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 40	-0.24 score on scale Standard Error 0.24	0.39 score on scale Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: 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.

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 baseline at Weeks 2, 4, 8, 12 and 18 in DI total score is reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18 Week 12	-0.41 score on scale Standard Deviation 0.53	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18 Week 2	-0.15 score on scale Standard Deviation 0.41	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18 Week 4	-0.23 score on scale Standard Deviation 0.42	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18 Week 8	-0.36 score on scale Standard Deviation 0.46	—
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18 Week 18	-0.49 score on scale Standard Deviation 0.57	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, and 40

Population: 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.

CHAQ: 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 overall score, 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 Weeks 20, 24, 28, 32, 36, and 40 in DI total score is reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40 Week 32	0.01 score on scale Standard Deviation 0.04	0.10 score on scale Standard Deviation 0.05
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40 Week 20	0.05 score on scale Standard Deviation 0.04	0.08 score on scale Standard Deviation 0.04
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40 Week 24	0.01 score on scale Standard Deviation 0.03	0.08 score on scale Standard Deviation 0.04
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40 Week 28	-0.01 score on scale Standard Deviation 0.04	0.09 score on scale Standard Deviation 0.04
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40 Week 36	-0.04 score on scale Standard Deviation 0.04	0.08 score on scale Standard Deviation 0.05
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40 Week 40	-0.05 score on scale Standard Deviation 0.04	0.06 score on scale Standard Deviation 0.05

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 18

Population: 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.

CHQ: 50-item, 14 subscale (Global health, physical functioning, social limitations: emotional, social limitations: physical, bodily pain, behavior, global behavior, mental health, self-esteem, general health, Change in health, emotional impact on parent, time impact on parent, family activities, family cohesion) parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents. Each subscale rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Two summary scores: Physical Health and Psychosocial Health were weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Mental health	6.43 score on scale Standard Deviation 15.68	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Global health	13.86 score on scale Standard Deviation 22.40	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Global health	21.28 score on scale Standard Deviation 22.79	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Physical functioning	11.83 score on scale Standard Deviation 24.47	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Physical functioning	21.44 score on scale Standard Deviation 26.78	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Social limitations: emotional	8.12 score on scale Standard Deviation 29.29	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Social limitations: emotional	14.62 score on scale Standard Deviation 30.18	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Social limitations: physical	13.45 score on scale Standard Deviation 31.12	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Social limitations: physical	20.81 score on scale Standard Deviation 32.53	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Bodily pain	19.42 score on scale Standard Deviation 21.14	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Bodily pain	30.60 score on scale Standard Deviation 22.79	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Behavior	3.06 score on scale Standard Deviation 12.86	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Behavior	5.70 score on scale Standard Deviation 12.91	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Global behavior	7.40 score on scale Standard Deviation 23.27	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Global behavior	9.30 score on scale Standard Deviation 24.97	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Mental health	6.74 score on scale Standard Deviation 16.06	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Self esteem	2.42 score on scale Standard Deviation 19.47	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Self esteem	8.45 score on scale Standard Deviation 17.35	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: General health	4.20 score on scale Standard Deviation 13.50	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: General health	7.02 score on scale Standard Deviation 14.31	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Change in Health	0.86 score on scale Standard Deviation 1.20	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Change in Health	1.70 score on scale Standard Deviation 1.32	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Emotional impact on parent	9.02 score on scale Standard Deviation 26.30	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Emotional impact on parent	15.38 score on scale Standard Deviation 29.35	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Time impact on parent	6.17 score on scale Standard Deviation 24.64	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Time impact on parent	9.99 score on scale Standard Deviation 23.38	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Family activities	5.19 score on scale Standard Deviation 15.15	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Family activities	9.59 score on scale Standard Deviation 19.63	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Family cohesion	2.78 score on scale Standard Deviation 21.80	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Family cohesion	3.62 score on scale Standard Deviation 18.81	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Physical Health Summary	8.12 score on scale Standard Deviation 11.18	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Physical Health Summary	13.36 score on scale Standard Deviation 12.57	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 4: Psychosocial Health Summary	2.46 score on scale Standard Deviation 8.13	—
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18 Week 18: Psychosocial Health Summary	4.20 score on scale Standard Deviation 8.41	—

SECONDARY outcome

Timeframe: Double-Blind Baseline (Week 18), Week 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 General Health	7.91 score on a scale Standard Error 1.84	6.14 score on a scale Standard Error 2.26
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Global health	5.46 score on a scale Standard Error 2.83	1.66 score on a scale Standard Error 3.72
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Global Behavior	-2.61 score on a scale Standard Error 2.89	1.04 score on a scale Standard Error 3.54
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Family Activities	0.01 score on a scale Standard Error 2.39	8.61 score on a scale Standard Error 2.95
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Physical Health Summary	1.67 score on a scale Standard Error 1.48	-1.81 score on a scale Standard Error 1.85
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Psychosocial Health Summary	0.64 score on a scale Standard Error 1.22	1.39 score on a scale Standard Error 1.52
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Physical functioning	1.45 score on a scale Standard Error 3.16	-1.82 score on a scale Standard Error 3.92
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Social Limitations: Emotional	1.78 score on a scale Standard Error 3.53	-3.69 score on a scale Standard Error 4.36
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Social Limitations: Physical	-3.08 score on a scale Standard Error 4.03	-10.29 score on a scale Standard Error 5.04
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Bodily Pain	6.34 score on a scale Standard Error 3.13	-1.91 score on a scale Standard Error 3.91
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Behavior	0.78 score on a scale Standard Error 2.09	4.20 score on a scale Standard Error 2.57
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Mental Health	0.41 score on a scale Standard Error 2.53	3.88 score on a scale Standard Error 3.12
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Self Esteem	1.48 score on a scale Standard Error 3.29	0.76 score on a scale Standard Error 4.07
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Change in Health	0.07 score on a scale Standard Error 0.10	0.09 score on a scale Standard Error 0.12
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Emotional Impact on Parent	9.55 score on a scale Standard Error 4.32	0.58 score on a scale Standard Error 5.35
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Time Impact on Parent	-3.83 score on a scale Standard Error 2.92	2.89 score on a scale Standard Error 3.62
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44 Family Cohesion	6.04 score on a scale Standard Error 3.18	3.45 score on a scale Standard Error 3.92

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: 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.

CHAQ is a validated instrument and comprises of two indices, Disability and Discomfort, and global assessment of arthritis (overall well-being). Discomfort Index included: assessment of discomfort, the parent/legal guardian/participant were asked to provide a response to the question: How much pain do you think your child had because of his or her illness in the past week?, The parent/legal guardian/ participant rated the overall pain on a 0 to 10 VAS, where '0' indicates 'No Pain' and '10' indicates 'Very Severe Pain', higher scores indicates more severity.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=184 Participants 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).	Placebo 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).
Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18 Week 2	-1.32 score on scale Standard Deviation 2.10	—
Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18 Week 4	-2.06 score on scale Standard Deviation 2.16	—
Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18 Week 8	-2.38 score on scale Standard Deviation 2.40	—
Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18 Week 12	-2.72 score on scale Standard Deviation 2.28	—
Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18 Week 18	-3.04 score on scale Standard Deviation 2.57	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36,40 and 44

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=72 Participants 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).	Placebo n=70 Participants 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).
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 32	0.07 score on scale Standard Deviation 0.27	1.06 score on scale Standard Deviation 0.29
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 36	-0.21 score on scale Standard Deviation 0.21	0.32 score on scale Standard Deviation 0.24
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 44	-0.36 score on scale Standard Deviation 0.23	0.44 score on scale Standard Deviation 0.25
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 20	0.08 score on scale Standard Deviation 0.20	0.40 score on scale Standard Deviation 0.20
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 24	-0.01 score on scale Standard Deviation 0.24	0.94 score on scale Standard Deviation 0.24
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 28	-0.23 score on scale Standard Deviation 0.24	0.64 score on scale Standard Deviation 0.25
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 40	-0.22 score on scale Standard Deviation 0.24	0.49 score on scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline

Population: The OLFAS consists 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.

Uveitis is the inflammation of the uvea. Participants were assessed for presence of uveitis (according to Standard Uveitis Nomenclature \[SUN\]). If Uveitis was present in participant at Baseline, it was considered as "active uveitis"; If Uveitis was not present in participant at Baseline, it was considered as "Inactive uveitis". As per SUN, Uveitis is defined as: anterior (in which anterior chamber is primary site of inflammation); intermediate (primary site of inflammation: vitreous); posterior (primary site of inflammation: retina or choroid). Percentage of participants with active uveitis (of any type) are reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=225 Participants 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).	Placebo 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).
Open-Label Phase: Percentage of Participants With Active Uveitis at Baseline	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 24 and Week 44

Population: The double-blind safety analysis set (DBSAS) consists of all participants who have received at least one dose of study medication in double-blind phase.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=88 Participants 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).	Placebo n=85 Participants 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).
Double Blind Phase: Percentage of Participants With Active Uveitis at Week 24 and Week 44 Week 44: Present	0.0 percentage of participants	0.0 percentage of participants
Double Blind Phase: Percentage of Participants With Active Uveitis at Week 24 and Week 44 Week 24: Present	0.0 percentage of participants	1.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, weeks 2, 4, 8, 12 and 18

Population: OLERA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Participants with enthesitis-related arthritis (ERA) undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66\*(total number of tender entheses with counts \> 0)/number of non-missing tender entheses. If \> 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=21 Participants 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).	Placebo 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).
Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18 Week 2	-1.57 tender entheses score Standard Deviation 3.61	—
Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18 Week 4	-2.52 tender entheses score Standard Deviation 3.92	—
Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18 Week 8	-3.05 tender entheses score Standard Deviation 4.45	—
Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18 Week 12	-3.15 tender entheses score Standard Deviation 4.93	—
Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18 Week 18	-3.50 tender entheses score Standard Deviation 4.70	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: DBERA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with ERA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Participants with ERA undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66\*(total number of tender entheses with counts \> 0)/number of non-missing tender entheses. If \> 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=9 Participants 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).	Placebo n=7 Participants 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).
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 20	0.00 tender entheses score Standard Deviation 0.87	0.86 tender entheses score Standard Deviation 2.61
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 24	-1.00 tender entheses score Standard Deviation 3.46	0.40 tender entheses score Standard Deviation 2.19
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 28	-0.43 tender entheses score Standard Deviation 2.57	-0.75 tender entheses score Standard Deviation 0.96
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 32	0.33 tender entheses score Standard Deviation 1.97	0.00 tender entheses score Standard Deviation 0.82
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 36	-0.83 tender entheses score Standard Deviation 2.04	0.33 tender entheses score Standard Deviation 0.58
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 40	-2.00 tender entheses score Standard Deviation 4.47	0.33 tender entheses score Standard Deviation 0.58
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 44	-2.00 tender entheses score Standard Deviation 5.66	-0.33 tender entheses score Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Participants with ERA undergo Modified Schober's Test. In the Modified Schober's Test, a mark was placed 5 cm below the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 cm above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter and is reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=21 Participants 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).	Placebo 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).
Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18 Week 2	-0.35 centimeter (cm) Standard Deviation 1.02	—
Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18 Week 4	-0.20 centimeter (cm) Standard Deviation 1.03	—
Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18 Week 8	-0.12 centimeter (cm) Standard Deviation 1.15	—
Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18 Week 12	0.02 centimeter (cm) Standard Deviation 1.05	—
Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18 Week 18	0.29 centimeter (cm) Standard Deviation 1.08	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=9 Participants 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).	Placebo n=7 Participants 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).
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44 Week 20	-0.46 cm Standard Deviation 1.61	-0.28 cm Standard Deviation 0.47
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44 Week 24	-0.44 cm Standard Deviation 1.27	-0.35 cm Standard Deviation 0.54
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44 Week 40	0.57 cm Standard Deviation 1.62	0.85 cm Standard Deviation 0.64
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44 Week 28	0.32 cm Standard Deviation 1.38	-0.17 cm Standard Deviation 0.57
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44 Week 32	0.42 cm Standard Deviation 1.84	0.63 cm Standard Deviation 1.26
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44 Week 36	-0.53 cm Standard Deviation 0.84	0.05 cm Standard Deviation 0.21
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44 Week 44	0.50 cm Standard Deviation 0.87	1.05 cm Standard Deviation 2.47

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Participants with ERA undergo Overall Back Pain and Nocturnal Back Pain assessment. For Overall Back Pain, parent/legal guardian/participant were asked to provide a response to the question: What is the amount of back pain at any time that your child experienced in the past week? And For Nocturnal Back Pain: What is the amount of back pain at night that your child experienced in the past week?. Response to these questions was provided by parent/legal guardian/participant using a VAS of 0-10, where 0= No Pain and 10= Most Severe Pain, higher score indicated more severe pain.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=21 Participants 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).	Placebo 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).
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 2: Overall back pain	-1.81 score on scale Standard Deviation 2.89	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 4: Overall back pain	-1.86 score on scale Standard Deviation 3.29	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 2: Nocturnal Back Pain	-1.21 score on scale Standard Deviation 3.10	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 4: Nocturnal Back Pain	-1.33 score on scale Standard Deviation 3.44	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 8: Nocturnal Back Pain	-1.80 score on scale Standard Deviation 3.18	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 12: Nocturnal Back Pain	-2.30 score on scale Standard Deviation 2.63	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 18: Nocturnal Back Pain	-1.98 score on scale Standard Deviation 2.94	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 8:Overall back pain	-2.65 score on scale Standard Deviation 2.72	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 12:Overall back pain	-3.20 score on scale Standard Deviation 2.54	—
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18 Week 18: Overall back pain	-3.30 score on scale Standard Deviation 2.45	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=9 Participants 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).	Placebo n=7 Participants 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).
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 44: Overall back pain	-0.10 score on scale Standard Deviation 3.45	-0.50 score on scale Standard Deviation 0.87
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 20: Nocturnal Back Pain	-0.17 score on scale Standard Deviation 0.87	0.57 score on scale Standard Deviation 0.93
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 24: Nocturnal Back Pain	-1.06 score on scale Standard Deviation 1.96	0.10 score on scale Standard Deviation 0.42
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 28: Nocturnal Back Pain	-0.79 score on scale Standard Deviation 2.00	0.00 score on scale Standard Deviation 0.41
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 32: Nocturnal Back Pain	-1.58 score on scale Standard Deviation 1.63	0.38 score on scale Standard Deviation 0.63
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 36: Nocturnal Back Pain	-0.75 score on scale Standard Deviation 2.27	0.17 score on scale Standard Deviation 0.29
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 40: Nocturnal Back Pain	-2.00 score on scale Standard Deviation 2.26	0.17 score on scale Standard Deviation 0.29
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 44: Nocturnal Back Pain	-0.80 score on scale Standard Deviation 2.20	0.17 score on scale Standard Deviation 0.29
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 20: Overall back pain	0.28 score on scale Standard Deviation 1.89	0.57 score on scale Standard Deviation 1.40
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 24: Overall back pain	0.39 score on scale Standard Deviation 2.10	0.00 score on scale Standard Deviation 0.79
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 28: Overall back pain	0.00 score on scale Standard Deviation 2.60	-0.25 score on scale Standard Deviation 0.29
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 32:Overall back pain	-1.75 score on scale Standard Deviation 2.25	-0.13 score on scale Standard Deviation 0.48
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 36: Overall back pain	0.17 score on scale Standard Deviation 1.29	-0.50 score on scale Standard Deviation 0.87
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44 Week 40: Overall back pain	0.30 score on scale Standard Deviation 1.79	-0.50 score on scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: OLPsA (OL psoriatic arthritis PsA) included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with PsA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to proximal interphalangeal (PIP) and thumb =\\together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% \[10 palms\], Upper extremities = 20% \[20 palms\], Trunk \[axillae and groin\] = 30% \[30 palms\], Lower extremities \[buttocks\] = 40% \[40 palms\]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=20 Participants 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).	Placebo 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).
Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18 Week 4	-1.03 percentage of BSA Standard Deviation 2.49	—
Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18 Week 2	0.55 percentage of BSA Standard Deviation 4.70	—
Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18 Week 8	-0.29 percentage of BSA Standard Deviation 6.11	—
Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18 Week 12	-0.36 percentage of BSA Standard Deviation 5.93	—
Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18 Week 18	-0.46 percentage of BSA Standard Deviation 6.48	—

SECONDARY outcome

Timeframe: Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Population: DBPsA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with PsA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to PIP and thumb together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% \[10 palms\], Upper extremities = 20% \[20 palms\], Trunk \[axillae and groin\] = 30% \[30 palms\], Lower extremities \[buttocks\] = 40% \[40 palms\]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=7 Participants 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).	Placebo n=8 Participants 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).
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44 Week 24	-0.14 percentage of BSA Standard Deviation 0.38	0.85 percentage of BSA Standard Deviation 1.71
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44 Week 20	-0.50 percentage of BSA Standard Deviation 1.22	0.28 percentage of BSA Standard Deviation 0.70
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44 Week 28	-4.20 percentage of BSA Standard Deviation 8.84	0.33 percentage of BSA Standard Deviation 0.58
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44 Week 32	-0.60 percentage of BSA Standard Deviation 1.34	1.67 percentage of BSA Standard Deviation 2.89
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44 Week 36	-4.20 percentage of BSA Standard Deviation 8.90	1.33 percentage of BSA Standard Deviation 2.31
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44 Week 40	-4.60 percentage of BSA Standard Deviation 8.71	0.67 percentage of BSA Standard Deviation 1.15
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44 Week 44	-4.60 percentage of BSA Standard Deviation 8.71	-0.05 percentage of BSA Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: OLPsA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with PsA. Here, "n" signifies participants evaluable for this outcome measure at specified time points.

The PGA of psoriasis was scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 5 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and ranged as 0= no symptom to 5=severe, higher score indicates more severity.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=20 Participants 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).	Placebo 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).
Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18 Week 2	-0.05 score on scale Standard Deviation 0.39	—
Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18 Week 4	-0.42 score on scale Standard Deviation 0.84	—
Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18 Week 8	-0.29 score on scale Standard Deviation 0.92	—
Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18 Week 12	-0.56 score on scale Standard Deviation 0.86	—
Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18 Week 18	-0.56 score on scale Standard Deviation 1.03	—

SECONDARY outcome

Timeframe: Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=7 Participants 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).	Placebo n=8 Participants 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).
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 32	0.00 score on scale Standard Deviation 0.00	0.33 score on scale Standard Deviation 0.58
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 20	0.14 score on scale Standard Deviation 0.38	0.00 score on scale Standard Deviation 0.00
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 24	0.14 score on scale Standard Deviation 0.38	0.38 score on scale Standard Deviation 0.52
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 28	0.20 score on scale Standard Deviation 0.45	0.33 score on scale Standard Deviation 0.58
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 36	0.00 score on scale Standard Deviation 0.00	0.33 score on scale Standard Deviation 0.58
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 40	0.00 score on scale Standard Deviation 0.00	0.00 score on scale Standard Deviation 0.00
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44 Week 44	0.00 score on scale Standard Deviation 0.00	-0.50 score on scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Day 14

Population: The OLFAS consists 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. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Oral solution was given only to participants weighing \<40 kg and to the participants who were unable to swallow tablets. Taste assessment was evaluated using a 5 categories questionnaire. Participants were asked to answer in one of the following categories to describe the taste of oral solution of tofacitinib: dislike very much, dislike a little, not sure, like a little and like very much. Number of participants within each category are reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=84 Participants 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).	Placebo 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).
Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14 Dislike Very Much	4 Participants	—
Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14 Dislike a Little	8 Participants	—
Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14 Not Sure	6 Participants	—
Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14 Like a Little	32 Participants	—
Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14 Like Very Much	34 Participants	—

SECONDARY outcome

Timeframe: From the first dose of study drug up to Week 18

Population: The OLFAS consists 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.

Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts: \<500 lymphocytes/ millimeter\^3 (mm), neutrophil counts \<1000 neutrophils/mm\^3, platelet counts \<100,000 platelets/mm\^3, any single hemoglobin value \<8 grams/decilitre (g/dL) and any single hemoglobin value drops \>=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=225 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Serious Infections	3 Participants	—
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia: Lymphocyte counts <500 lymphocytes/mm^3	1 Participants	—
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia:Neutrophil counts <1000 neutrophils/mm^3	4 Participants	—
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia: Platelet counts <100,000 platelets/mm^3	1 Participants	—
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia: Any single hg value <8 g/dL	1 Participants	—
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia:Any hg value drops>=2g/dL below baseline	17 Participants	—
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Malignancies	0 Participants	—
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cardiovascular Diseases	0 Participants	—

SECONDARY outcome

Timeframe: From the first dose of study drug in double blind up to week 44

Population: The DBFAS consists of all participants randomized to double-blind phase who received at least one dose of study medication in double-blind phase.

Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts \<500 lymphocytes/mm\^3, neutrophil counts \<1000 neutrophils/mm\^3, platelet counts \<100000 platelets/mm\^3, any single hemoglobin (hg) value \<8 g/dL and any single hemoglobin value drops \>=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=88 Participants 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).	Placebo n=85 Participants 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).
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Serious Infections	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia: Any single hemoglobin value <8 g/dL	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Malignancies	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia: Lymphocyte counts <500 lymphocytes/mm^3	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia:Neutrophil counts <1000 neutrophils/mm^3	0 Participants	2 Participants
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia: Platelet counts <100,000 platelets/mm^3	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cytopenia: hg value drops >=2 g/dL below baseline	3 Participants	7 Participants
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases Cardiovascular Diseases	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Day 1 was summarized and reported using number of participants in each stage.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=218 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 1	73 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 2	21 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 3	25 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 4	47 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 5	52 Participants	—

SECONDARY outcome

Timeframe: Week 44

Population: The double-blind safety analysis set (DBSAS) consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males) were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Week 44 was summarized and reported using number of participants in each stage.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=56 Participants 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).	Placebo n=38 Participants 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).
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 4	14 Participants	4 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 1	13 Participants	7 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 2	8 Participants	7 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 3	8 Participants	3 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair) Stage 5	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Day 1

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming "double scoop" appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Day 1 was summarized and reported using number of participants in each stage.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=163 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 1	42 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 2	19 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 3	28 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 4	34 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 5	40 Participants	—

SECONDARY outcome

Timeframe: Week 44

Population: The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming "double scoop" appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Week 44 was summarized and reported using number of participants in each stage.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=43 Participants 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).	Placebo n=28 Participants 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).
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 1	6 Participants	8 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 2	8 Participants	2 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 3	7 Participants	2 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 4	13 Participants	3 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam) Stage 5	9 Participants	13 Participants

SECONDARY outcome

Timeframe: Day 1

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume \< 4 ml or long axis \< 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: \> 20 ml (or \> 4.5 cm long). Tanner Stage for genitalia at Day 1 was summarized and reported using number of participants in each stage.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=55 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 1	24 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 2	6 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 3	8 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 4	11 Participants	—
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 5	6 Participants	—

SECONDARY outcome

Timeframe: Week 44

Population: The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume \< 4 ml or long axis \< 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: \> 20 ml (or \> 4.5 cm long). Tanner Stage for genitalia at Week 44 was summarized and reported using number of participants in each stage.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=13 Participants 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).	Placebo n=10 Participants 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).
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 1	5 Participants	0 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 2	0 Participants	5 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 3	2 Participants	0 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 4	5 Participants	1 Participants
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia) Stage 5	1 Participants	4 Participants

SECONDARY outcome

Timeframe: From the first dose of study drug up to Week 18

Population: The OLFAS consists 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. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Criteria: Hemoglobin(Hg),hematocrit erythrocytes(Ery); \<0.8\*lower limit of normal (LLN), Ery. Mean Corpuscular Volume; \<0.9\*LLN, \>1.1\*upper limit of normal (ULN), Platelets; \<0.5\*LLN, \>1.75\*ULN, Leukocytes (leu); \<0.6\*LLN, \>1.5\*ULN, Lymphocytes (Ly), Ly/leu, Neutrophils, Neutrophils/leu \<0.8\*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu \>1.2\*ULN, Ery Sedimentation Rate \>1.5\*ULN. Bilirubin, Indirect Bilirubin \>1.5\*ULN, AST, ALT, Gamma Glutamyl Transferase, Alkaline Phosphatase \>3.0\*ULN, Albumin \>1.2\*ULN, Creatinine \>1.3\*ULN, HDL Cholesterol (Chol)\<0.8\*LLN, LDL Chol, LDL Chol Friedewald Est PEG \>1.2\*ULN, Triglycerides \>1.3\*ULN, Calcium \<0.9\*LLN, Bicarbonate \<0.9\*LLN, Glucose \>1.5\*ULN, Creatine Kinase \>2.0\*ULN, C Reactive Protein \>1.1\*ULN, Chol \>1.3\*ULN. Urinalysis: Specific Gravity \>1.030, Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase \>=1, Ery, Leu \>=20, Hyaline Casts \>1.Only those category in which at least 1 participant had data is reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=225 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Laboratory Abnormalities Platelets (<0.5*LLN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Monocytes (>1.2*ULN)	3 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Indirect Bilirubin (>1.5*ULN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Alanine Aminotransferase (ALT) (>3.0*ULN)	5 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Albumin (>1.2*ULN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities HDL Cholesterol (<0.8*LLN)	2 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities LDL Chol Friedewald Est PEG (>1.2*ULN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Creatine Kinase (>2.0*ULN)	12 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Cholesterol (>1.3*ULN)	2 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Ketones (>=1)	11 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities URINE Leukocytes (>=20)	16 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Hyaline Casts (>1)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Hemoglobin (<0.8* LLN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Hematocrit (<0.8* LLN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Erythrocytes (<0.8* LLN)	2 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Ery. Mean Corpuscular Volume (<0.9*LLN)	3 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Ery. Mean Corpuscular Volume (>1.1*ULN )	4 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Platelets (>1.75*ULN)	2 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Leukocytes (<0.6*LLN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Leukocytes (>1.5*ULN)	2 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Lymphocytes (<0.8*LLN)	7 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Lymphocytes (>1.2*ULN)	2 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Lymphocytes/Leukocytes (<0.8*LLN)	15 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Lymphocytes/Leukocytes (>1.2*ULN)	20 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Neutrophils (<0.8*LLN)	8 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Neutrophils (>1.2*ULN)	18 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Neutrophils/Leukocytes (<0.8*LLN)	19 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Basophils/Leukocytes (>1.2*ULN)	37 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Eosinophils (>1.2*ULN)	53 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Eosinophils/Leukocytes (>1.2*ULN)	32 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Monocytes/Leukocytes (>1.2*ULN)	38 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Ery. Sedimentation Rate (>1.5*ULN)	65 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Bilirubin (>1.5*ULN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Aspartate Aminotransferase (AST) (>3.0*ULN)	4 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities GGT (>3.0*ULN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Alkaline Phosphatase (>3.0*ULN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Creatinine (>1.3*ULN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities LDL Cholesterol (>1.2*ULN)	4 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Triglycerides (>1.3*ULN)	27 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Calcium (<0.9*LLN)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Bicarbonate (<0.9*LLN)	10 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Glucose (>1.5*ULN)	2 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities C Reactive Protein (>1.1*ULN)	122 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Specific Gravity (>1.030)	32 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities URINE Glucose (>=1)	1 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities URINE Protein (>=1)	9 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities URINE Hemoglobin (>=1)	48 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Nitrite (>=1)	6 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities Leukocyte Esterase (>=1)	59 Participants	—
Open-Label Phase: Number of Participants With Laboratory Abnormalities URINE Erythrocytes (>=1)	23 Participants	—

SECONDARY outcome

Timeframe: From the first dose of study drug in double blind up to Week 44

Population: The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase.

Criteria: Hg, hematocrit Ery; \<0.8\* LLN, Ery. Mean Corpuscular Volume; \<0.9\*LLN, \>1.1\* ULN, Platelets; \<0.5\*LLN, \>1.75\*ULN, leu; \<0.6\*LLN, \>1.5\*ULN, Ly, Ly/leu, Neutrophils, Neutrophils/leu \<0.8\*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu \>1.2\*ULN, Prothrombin Time \>1.1\*ULN, Ery Sedimentation Rate \>1.5\*ULN. Bilirubin, Direct Bilirubin, Indirect Bilirubin \>1.5\*ULN, AST, ALT, Gamma Glutamyl Transferase (GGT), Alkaline Phosphatase \>3.0\*ULN, Albumin \>1.2\*ULN, Creatinine \>1.3\*ULN, HDL Cholesterol (Chol)\<0.8\*LLN, LDL Chol, LDL Chol Friedewald Est PEG \>1.2\*ULN, Triglycerides \>1.3\*ULN, Calcium \<0.9\*LLN, Bicarbonate \<0.9\*LLN, Glucose \>1.5\*ULN, Creatine Kinase \>2.0\*ULN, C Reactive Protein \>1.1\*ULN, Chol \>1.3\*ULN. Urinalysis: Specific Gravity \>1.030, pH \>8, urine Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase \>=1, Ery, Leu \>=20, Hyaline Casts \>1.Only those category in which at least 1 participant had data is reported.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=88 Participants 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).	Placebo n=85 Participants 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).
Double Blind Phase: Number of Participants With Laboratory Abnormalities Hematocrit (<0.8*LLN)	0 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Leukocytes (>1.5*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Lymphocytes/Leukocytes (>1.2*ULN)	5 Participants	7 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Neutrophils (<0.8*LLN)	1 Participants	3 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Eosinophils/Leukocytes (>1.2*ULN)	21 Participants	14 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Prothrombin Time (>1.1*ULN)	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Ery. Sedimentation Rate (>1.5*ULN)	26 Participants	19 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities URINE Glucose (>=1)	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities URINE Leukocytes (>=20)	6 Participants	6 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Bilirubin (>1.5*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Direct Bilirubin (>1.5*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Indirect Bilirubin (>1.5*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Alanine Aminotransferase(>3.0*ULN)	1 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities GGT (>3.0*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities HDL Cholesterol (<0.8*LLN)	0 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Triglycerides (>1.3*ULN)	8 Participants	6 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Potassium (>1.1*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Calcium (<0.9*LLN )	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Glucose (>1.5*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Creatine Kinase (>2.0*ULN)	2 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities C Reactive Protein (>1.1*ULN)	44 Participants	47 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Specific Gravity (>1.030)	12 Participants	7 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities pH (>8)	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Ketones (>=1)	7 Participants	10 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities URINE Protein (>=1)	4 Participants	4 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities URINE Hemoglobin (>=1)	25 Participants	11 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Nitrite (>=1)	3 Participants	6 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Leukocyte Esterase (>=1)	26 Participants	25 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities URINE Erythrocytes (>=20)	10 Participants	6 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Hyaline Casts (>1)	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Granular Casts (>1)	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Bicarbonate (<0.9*LLN)	0 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Hemoglobin (<0.8*LLN)	1 Participants	3 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Erythrocytes (<0.8*LLN)	0 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Ery. Mean Corpuscular Volume (<0.9*LLN)	2 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Ery. Mean Corpuscular Volume (>1.1*ULN)	1 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Platelets (<0.5*LLN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Leukocytes (<0.6*LLN)	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Lymphocytes (<0.8*LLN)	5 Participants	1 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Lymphocytes (>1.2*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Lymphocytes/Leukocytes (<0.8*LLN)	9 Participants	5 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Neutrophils (>1.2*ULN)	7 Participants	5 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Neutrophils/Leukocytes (<0.8*LLN)	5 Participants	6 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Basophils (>1.2*ULN)	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Basophils/Leukocytes (>1.2*ULN)	14 Participants	15 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Eosinophils (>1.2*ULN)	27 Participants	18 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Monocytes (>1.2*ULN)	2 Participants	2 Participants
Double Blind Phase: Number of Participants With Laboratory Abnormalities Monocytes/Leukocytes (>1.2*ULN)	18 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 and 18

Population: The OLFAS consists 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. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Physical examination included: abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, lymph nodes, neurological, nose, skin, and throat. Abnormality in physical examination was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=225 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Extremities: Baseline	49 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 2	43 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 4	35 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 8	30 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 12	28 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 2	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Baseline	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 2	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 4	3 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 8	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 12	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 18	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Ears: Baseline	5 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 8	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 18	3 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 18	23 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Eyes: Baseline	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 8	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 18	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities General appearance: Baseline	16 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 4	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 8	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 18	5 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Head: Baseline	3 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Head: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Head: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Head: Week 8	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Head: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Head: Week 18	4 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Heart: Baseline	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 8	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 18	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lungs: Baseline	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 8	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 12	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 18	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Baseline	2 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 2	5 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 4	5 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 8	5 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 12	3 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 18	4 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Neurological: Baseline	4 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 2	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 8	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 18	4 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Nose: Baseline	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 8	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 18	5 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Skin: Baseline	27 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 4	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 8	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 18	12 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Throat: Baseline	1 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 2	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 4	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 8	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 12	0 Participants	—
Open-Label Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 18	6 Participants	—

SECONDARY outcome

Timeframe: Weeks 18, 20, 24, 28, 32, 36, 40 and 44

Population: The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=88 Participants 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).	Placebo n=85 Participants 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).
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Head: Week 18	3 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Head: Week 32	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Head: Week 44	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 18	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 20	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 40	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 44	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 40	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 20	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 18	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 20	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 24	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 36	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 40	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Abdomen: Week 44	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 18	3 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 20	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 40	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Ears: Week 44	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 18	9 Participants	12 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 20	11 Participants	14 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 24	5 Participants	7 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 28	6 Participants	6 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 32	1 Participants	8 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 36	2 Participants	6 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 40	3 Participants	6 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Extremities: Week 44	3 Participants	7 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 18	2 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 20	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 40	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Eyes: Week 44	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 18	2 Participants	3 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 20	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 40	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities General appearance: Week 44	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Head: Week 20	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Head: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Head: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Head: Week 40	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 36	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 40	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Heart: Week 44	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 18	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 20	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 24	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 28	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lungs: Week 36	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 18	3 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 20	3 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 24	2 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 28	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 32	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 36	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 40	2 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Lymph nodes: Week 44	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 18	3 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 20	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 40	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Neurological: Week 44	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 18	4 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 20	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Nose: Week 44	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 18	8 Participants	4 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 20	3 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 24	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 40	1 Participants	1 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Skin: Week 44	4 Participants	2 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 18	4 Participants	2 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 24	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 28	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 32	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 40	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Physical Examination Abnormalities Throat: Week 44	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first dose of study drug up to Week 18

Population: The OLFAS consists 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. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Vital Sign Abnormalities criteria included: sitting diastolic blood pressure millimeters of Mercury (mmHG) of \<50 mmHg, sitting pulse rate beats per minute (bpm) of \<40 or 120 bpm, sitting systolic blood pressure (mmHG) of \<90 mmHg, supine diastolic blood pressure (mmHG) of \<50 mmHg, supine pulse rate (BPM) of \<40 bpm or \>120 bpm, supine systolic blood pressure (mmHG) of 90 mmHg.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=225 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Sitting diastolic BP ([mmHg]): <50 mmHg	0 Participants	—
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Sitting pulse rate (bpm): <40 bpm	0 Participants	—
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Sitting pulse rate (bpm): >120 bpm	5 Participants	—
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Sitting systolic BP (mmHg): <90 mmHg	0 Participants	—
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Supine diastolic BP (mmHg): <50 mmHg	2 Participants	—
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Supine pulse rate (bpm): <40 bpm	0 Participants	—
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Supine pulse rate (bpm): >120 bpm	0 Participants	—
Open-Label Phase: Number of Participants With Vital Sign Abnormalities Supine systolic BP (mmHg): <90 mmHg	2 Participants	—

SECONDARY outcome

Timeframe: From the first dose of study drug in double blind up to week 44

Population: The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure and "n" signifies participants evaluable for this outcome measure at specified time points.

Vital Sign Abnormalities criteria included: diastolic blood pressure (mmHG) of \<50 mmHg, Pulse rate (BPM) of \<40 bpm or \>120 bpm, sitting diastolic blood pressure (mmHG) of \<50 mmHg, sitting pulse rate beats per minute (bpm) of \<40 bpm or \>120 bpm, sitting systolic blood pressure (mmHG) of \<90 mmHg, supine diastolic blood pressure (mmHG) of \<50 mmHg, supine pulse rate (BPM) of \<40 bpm or \>120 bpm, supine systolic blood pressure (mmHG) of \<90 mmHg, systolic blood pressure (mmHG) of \<90 mmHg.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=87 Participants 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).	Placebo n=82 Participants 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).
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Diastolic BP (mmHg): <50 mmHg	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Pulse rate (bpm): <40 bpm	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Pulse rate (bpm): >120 bpm	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Sitting diastolic BP (mmHg): <50 mmHg	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Sitting pulse rate (bpm): <40 bpm	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Sitting pulse rate (bpm): >120 bpm	0 Participants	1 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Sitting systolic BP (mmHg): <90 mmHg	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Supine diastolic BP (mmHg): <50 mmHg	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Supine pulse rate (bpm): <40 bpm	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Supine pulse rate (bpm): >120 bpm	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Supine systolic BP (mmHg): <90 mmHg	1 Participants	0 Participants
Double Blind Phase: Number of Participants With Vital Sign Abnormalities Systolic BP (mmHg): <90 mmHg	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first dose of study drug up to Week 18

Population: OLFAS: all participants who were enrolled into OL phase of study and received at least one dose of study medication in open-label phase.Here, 'n' signifies participants evaluable for this outcome measure at specified time points.

Change in vital Signs included: Sitting diastolic blood pressure \[mmHG\]: \>=20mmHg increase from baseline (IFB) and \>= 20mmHg decrease from baseline (DFB). Sitting systolic blood pressure mmHG: \>= 30mmHg IFB and \>= 30mmHg DFB. Supine diastolic blood pressure mmHG: \>= 20mmHg IFB and \>= 20mmHg DFB. Supine systolic blood pressure mmHG: \>= 30mmHg IFB and \>= 30mmHg DFB.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=225 Participants 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).	Placebo 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).
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting diastolic BP: >= 20mmHg IFB	9 Participants	—
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting diastolic BP: >= 20mmHg DFB	14 Participants	—
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting systolic BP: >= 30mmHg IFB	2 Participants	—
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting systolic BP: >= 30mmHg DFB	5 Participants	—
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine diastolic BP: >= 20mmHg IFB	0 Participants	—
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine diastolic BP: >= 20mmHg DFB	3 Participants	—
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine systolic BP: >= 30mmHg IFB	0 Participants	—
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine systolic BP: >= 30mmHg DFB	3 Participants	—

SECONDARY outcome

Timeframe: From the first dose of study drug in double blind up to week 44

Change in vital Signs included: Sitting diastolic blood pressure (mmHG): \>=20mmHg IFB and \>= 20mmHg DFB. Sitting systolic blood pressure mmHG: \>= 30mmHg IFB and \>= 30mmHg DFB. Supine diastolic blood pressure mmHG: \>= 20mmHg IFB and \>= 20mmHg DFB. Supine systolic blood pressure mmHG: \>= 30mmHg IFB and \>= 30mmHg DFB.

Outcome measures

Outcome measures
Measure	Tofacitinib: Double Blind Phase n=87 Participants 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).	Placebo n=80 Participants 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).
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting diastolic BP: >= 20mmHg IFB	9 Participants	3 Participants
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting diastolic BP: >= 20mmHg DFB	7 Participants	9 Participants
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting systolic BP: >= 30mmHg IFB	3 Participants	4 Participants
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Sitting systolic BP: >= 30mmHg DFB	0 Participants	2 Participants
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine diastolic BP: >= 20mmHg IFB	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine diastolic BP: >= 20mmHg DFB	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine systolic BP: >= 30mmHg IFB	0 Participants	0 Participants
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures Supine systolic BP: >= 30mmHg DFB	0 Participants	0 Participants

Adverse Events

Tofacitinib: Open-Label Phase

Serious events: 7 serious events

Other events: 108 other events

Deaths: 0 deaths

Tofacitinib: Double Blind Phase

Serious events: 1 serious events

Other events: 57 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tofacitinib: Open-Label Phase n=225 participants at risk 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.	Tofacitinib: Double Blind Phase n=88 participants at risk 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).	Placebo n=85 participants at risk 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).
Gastrointestinal disorders Crohn's disease	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Diarrhoea	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Vomiting	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Condition aggravated	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Appendicitis	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	1.2% 1/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Epidural empyema	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Pneumonia	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Sinusitis	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Subperiosteal abscess	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Still's disease	0.44% 1/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Intussusception	0.00% 0/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	1.2% 1/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Juvenile idiopathic arthritis	0.00% 0/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	1.2% 1/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Surgical and medical procedures Pilonidal sinus repair	0.00% 0/225 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	1.1% 1/88 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/85 • From the first dose of study drug up to week 44 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER