Time to the disease flare=the number of days from randomization to flare in the DB phase and calculated as date of disease flare minus (-) date of randomization plus (+) 1. sJIA Flare=as at least one of the following criteria: Recurrence of fever >38 degree Celsius (C)/100.4 degree Fahrenheit (F) on 2 or more consecutive days) was considered due to SJIA activity. Worsening of 30 percent (%) or more in three or more of the six variables included: Number of joints with active arthritis and limited range of motion, disease activity, parent child evaluation of overall well-being, functional ability, childhood health assessment questionnaire ( CHAQ disability index), erythrocyte sedimentation rate (ESR) millimeter/ hour (mm/hr), of the JIA core set with no more than one variable of the JIA core set improving by 30% compared to the day of randomization into the withdrawal phase. 95% Confidence Interval (CI) based on Brookmeyer and Crowley Method.

Double blind full analysis set (DBFAS) consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

sJIA Flare was defined as at least one of the following criteria: recurrence of fever (>38° C/100.4 degree F) on 2 or more consecutive days) was considered due to SJIA activity. Worsening of 30% or more in three or more of the six variables: number of joints with active arthritis and limited range of motion, disease activity, parent child evaluation of overall well-being, functional ability (CHAQ Disability Index), ESR. of the JIA core set with no more than one variable of the JIA core set improving by 30% compared to the day of randomization into the withdrawal phase. Probability of occurrence of sJIA disease flare with 95% CI were estimated using Kaplan-Meier method and reported in this outcome measure.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

A successfully tapered participant was considered as the one that completed part 2 of the OL by reaching their target corticosteroid dose and maintained an adapted JIA American College of Rheumatology (ACR) 30 response for four weeks on this dose. The target CS dose at the end of part 2 included less than equal to (<=) 0.5 milligram/kilogram/day (mg/kg/day) up to a maximum dose of 15 milligram/ day (mg/day) oral prednisone (or equivalent) for CS>0.8 mg/kg/day oral prednisone; reduction to <=0.3 mg/kg/day up to a maximum of 12 mg/day oral prednisone (or equivalent) for CS <=0.8 mg/kg/day to greater than equal to (>=) 0.5 mg/kg/day oral prednisone (or equivalent) and <=0.2 mg/kg/day up to a maximum dose of 10 mg/day oral prednisone (or equivalent) for CS <0.5 mg/kg/day-CS˃0.2 mg/kg/day oral prednisone (or equivalent). 95% CI was based on normal approximation.

Open-label part 2 (OLP2) analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2.

95% CI was based on normal approximation.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2.

Adapted JIA ACR 30,50,70,90,100 response=absence of fever due to sJIA in preceding 7 days along with improvement of >=30,50,70,90,100%, respectively in at least 3 out of 6 JIA core set variables with no more than 1 JIA core set variable worsening by >=30%.Variables included: number of joints with active arthritis(any joint with swelling, or absence of swelling, limitation of motion accompanied by either pain on motion or tenderness);number of joints with limited range of motion; physician global evaluation of disease activity on VAS from 0=no disease activity to 10=very severe disease activity, higher scores:greater disease activity; parent/legal guardian/child evaluation of overall well-being on VAS from 0=very well to 10mm=very poor, higher scores: worsen condition; functional ability (Disability Index ranged from 0=no or minimal physical dysfunction, 3=very severe physical dysfunction, higher scores:more physical dysfunction;ESR (mm/hr).Missing response was imputed as non-response.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

Adapted JIA ACR 30,50,70,90,100 response=absence of fever due to sJIA in preceding 7 days along with improvement of >=30,50,70,90,100%, respectively in at least 3 out of 6 JIA core set variables with no more than 1 JIA core set variable worsening by >=30%.Variables included: number of joints with active arthritis(any joint with swelling, or absence of swelling, limitation of motion accompanied by either pain on motion or tenderness);number of joints with limited range of motion; physician global evaluation of disease activity on VAS from 0=no disease activity to 10=very severe disease activity, higher scores: greater disease activity; parent/legal guardian/child evaluation of overall well-being on VAS from 0=very well to 10mm=very poor, higher scores: worsen condition; functional ability (Disability Index ranged from 0=no or minimal physical dysfunction, 3=very severe physical dysfunction, higher scores: more physical dysfunction; ESR (mm/hr).

OLPT1 analysis set included all participants enrolled into the OL part 1 phase and received at least 1 dose of investigational product in part 1. All participants reported as 'Number of participants analyzed' contributed data to table; but may not have evaluable data for every row. Here, "Number analyzed" participants evaluable for specified time points and used for calculating percentages.

Adapted JIA ACR 30,50,70,90,100 response=absence of fever due to sJIA in preceding 7 days along with improvement of >=30,50,70,90,100%, respectively in at least 3 out of 6 JIA core set variables with no more than 1 JIA core set variable worsening by >=30%.Variables included: number of joints with active arthritis(any joint with swelling, or absence of swelling, limitation of motion accompanied by either pain on motion or tenderness);number of joints with limited range of motion; physician global evaluation of disease activity on VAS from 0=no disease activity to 10=very severe disease activity, higher scores: greater disease activity; parent/legal guardian/child evaluation of overall well-being on VAS from 0=very well to 10mm=very poor, higher scores: worsen condition; functional ability (Disability Index ranged from 0=no or minimal physical dysfunction, 3=very severe physical dysfunction, higher scores: more physical dysfunction; ESR (mm/hr).

OLPT2 analysis set included all participants enrolled into the OL part 2 phase and received at least 1 dose of investigational product in part 1. All participants reported as 'Number of participants analyzed' contributed data to table; but may not have evaluable data for every row. Here, "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

Fever was defined as an oral temperature of ˃38 degree Celsius/100.4 degree Fahrenheit. 95% CI was based on normal approximation.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies participants evaluable for the specified time points and used for calculating percentages.

Percentage of participants with CRP <= 10 milligrams per liter (mg/L) along with 95% CI based on normal approximation is reported in this outcome.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies participants evaluable for the specified time points and used for calculating percentages.

Percentage of participants with CRP <= 10 mg/L along with 95% CI based on normal approximation is reported in this outcome.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies participants evaluable for specified time points and used for calculating percentages.

Percentage of participants with absence of fever along with 95% CI based on normal approximation is reported in this outcome.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies participants evaluable for specified time points and used for calculating percentages.

Percentage of participants with absence of fever along with 95% CI based on normal approximation is reported in this outcome.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies participants evaluable for specified time points and used for calculating percentages.

Percentage of participants with absence of fever due sJIA is reported in this outcome. Missing response was imputed as non-response.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

Time to the first adapted JIA ACR 30 response was measured in number of days since Day 1 (day of adapted JIA ACR 30 response - Day 1 + 1) in the OL Phase Part 1. Participants that did not achieve an adapted JIA ACR30 response defined as absence of fever due to sJIA [temperature =<38 degree Celsius/100.4 degree F in the preceding 7 days along with an improvement of at least 30% from baseline (Day 1 of study drug before first tofacitinib administration) in at least 3 of the 6 JIA core components, with worsening of >=30 in no more than 1 of the remaining components, which in Part 1 (withdrew from the study) were censored at their last available response assessment in Part 1. 95% CI was based on the Brookmeyer and Crowley Method.](streamdown:incomplete-link)

OLPT1 analysis set included all participants who were enrolled into the OP part 1 phase of the study and received at least one dose of investigational product in part 1.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ) assessed on a VAS of 0 [very well] to 10 [very poor], ESR (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies participants evaluable for specified rows.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was determined based on four components: physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 [very well] to 10 [very poor]), CRP (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies participants evaluable for specified rows.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was determined based on four components: physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 [very well] to 10 [very poor]), ESR (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was determined based on four components: physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 [very well] to 10 [very poor]), CRP (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies participants evaluable for specified rows.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ) (assessed on a VAS of 0 [very well] to 10 [very poor]), ESR (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 [very well] to 10 [very poor]), CRP (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), Toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10= maximum disease activity. Where higher scores indicated more disease activity.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10= maximum disease activity. Where higher scores indicated more disease activity.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

ESR was determined using an ESR testing kit.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

ESR was determined using an ESR testing kit.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0= very well and 10=very poorly. Where higher scores indicated worse condition.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0=Very Well and 10=Very Poorly. Where higher scores indicated worse condition.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall Well-being. CHAQ disability index consisted of 30 items in 8 areas: 1. dressing and grooming, 2. arising, 3. eating, 4. walking, 5. hygiene, 6. reach, 7. grip, and 8. activities distributed. Each item was rated on a 4-point scale, scored from 0 (no difficulty) to 3 (unable to do). The eight areas of the CHAQ were averaged to calculate the total disability index score which ranged from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher scores indicated more disability. A participant must have score for at least six of the eight areas, otherwise a CHAQ-DI score was not valid.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. CHAQ disability index consisted of 30 items in 8 areas, 1. dressing and grooming, 2. arising, 3. eating, 4. walking, 5. hygiene, 6. reach, 7. grip, and 8. activities distributed. Each item was rated on a 4-point scale, scored from 0 (no difficulty) to-3 (unable to do). The eight areas of the CHAQ were averaged to calculate the total disability index score which ranged from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher scores indicated more disability. A participant must have score for at least six of the eight areas, otherwise a CHAQ-DI score was not valid.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The parents were asked to provide responses to questions designed to assessed function in 8 distributed, among a total of 30 items. Each question was rated on a four-point scale, scored from 0-3. The question with the highest score determined the score for the functional area. If aids or devices were used or assistance was required, the minimum score for that was 2. Each question was rated 0 for no difficulty, 1 for some difficulties, 2 for much difficulties, and 3 for unable to do. The 8 areas of the CHAQ were averaged to calculated disability index which was ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction). A participant must have score for at least 6 of the 8 categories, otherwise a CHAQ-DI score was not valid.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

The parents were asked to provide responses to questions designed to assessed function in 8 distributed, among a total of 30 items. Each question was rated on a four-point scale, scored from 0-3. The question with the highest score determined the score for the functional area. If aids or devices were used or assistance was required, the minimum score for that was 2. Each question was rated 0 for no difficulty, 1 for some difficulties, 2 for much difficulties, and 3 for unable to do. The 8 areas of the CHAQ were averaged to calculated disability index which was ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction). A participant must have score for at least 6 of the 8 categories, otherwise a CHAQ-DI score was not valid.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10=maximum disease activity, where higher scores indicated more disease activity.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10=maximum disease activity, where higher scores indicated more disease activity.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

ESR was determined using an ESR testing kit.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

ESR was determined using an ESR testing kit.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0'= very well' and '10= very poorly, where higher scores indicated worse condition.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0'= very well' and '10=very poorly.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

The CHQ is a validated general pediatric quality of life instrument. The CHQ assessed for 14 physical and psychosocial domains: general health perceptions (global health perception), physical functioning, role/social physical functioning, bodily pain, role/social emotional functioning, role/social behavioral functioning, parent/legal guardian/adult caregiver impact-time, parent/legal guardian/adult caregiver impact-emotional, self-esteem, mental health, behavior, family activities, family cohesion, and change in health. The response options for the CHQ are ordinal scales that vary by the item. Each item consisted of 4-6 response options. The CHQ score was determined based on the parent/legal guardian/adult caregiver's questionnaire responses. Range on subscales and the overall scale is 0 to 100, where 0 is the worst possible health state and 100 the best possible health state.

OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The CHQ is a validated general pediatric quality of life instrument. The CHQ assessed for 14 physical and psychosocial domains: general health perceptions (global health perception), physical functioning, role/social physical functioning, bodily pain, role/social emotional functioning, role/social behavioral functioning, parent/legal guardian/adult caregiver impact-time, parent/legal guardian/adult caregiver impact-emotional, self-esteem, mental health, behavior, family activities, family cohesion, and change in health. The response options for the CHQ are ordinal scales that vary by the item. Each item consisted of 4-6 response options. The CHQ score was determined based on the parent/legal guardian/adult caregiver's questionnaire responses. Range on subscales and the overall scale is 0 to 100, where 0 is the worst possible health state and 100 the best possible health state.

OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

The CHQ is a validated general pediatric quality of life instrument. The CHQ assessed for 14 physical and psychosocial domains: general health perceptions (global health perception), physical functioning, role/social physical functioning, bodily pain, role/social emotional functioning, role/social behavioral functioning, parent/legal guardian/adult caregiver impact-time, parent/legal guardian/adult caregiver impact-emotional, self-esteem, mental health, behavior, family activities, family cohesion, and change in health. The response options for the CHQ are ordinal scales that vary by the item. Each item consisted of 4-6 response options. The CHQ score was determined based on the parent/legal guardian/adult caregiver's questionnaire responses. Range on subscales and the overall scale is 0 to 100, where 0 is the worst possible health state and 100 the best possible health state.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

For the assessment of discomfort, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall pain the participant had due to illness by entering a number from 0 to 10 (in 0.5 increments), with '0' as 'no pain' and '10' as 'very severe pain' on a 21-circle VAS, where higher scores indicated more severe pain.

OLPT1 consisted of all participants who were enrolled into the OL part 1 and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.

For the assessment of discomfort, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall pain the participant had due to illness by entering a number from 0 to 10 (in 0.5 increments), with '0' as 'no pain' and '10' as 'very severe pain' on a 21-circle VAS, where higher scores indicated more pain.

OLPT2 consisted of all participants who were enrolled into the OL part 2 and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies number of participants evaluable for specified rows.

For the assessment of discomfort, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall pain the participant had due to illness by entering a number from 0 to 10 (in 0.5 increments), with '0' as 'no pain' and '10' as 'very severe pain' on a 21-circle VAS, where higher scores indicated more severe pain.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of: <= 3.8. For participants with oligoarthritis (<= 4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of <=2.

OLPT1 consisted of all participants who were enrolled into the OL part 1 and received at least one dose of investigational product in part 1. All participants reported under "Number of participants analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of: <= 3.8. For participants with oligoarthritis (<= 4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of <=2.

OLPT1 consisted of all participants who were enrolled into the OL part 1 and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of: <= 3.8. For participants with oligoarthritis (<= 4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of <=2.

OLPT2 consisted of all participants who were enrolled into the OL part 2 and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of: <= 3.8. For participants with oligoarthritis (<= 4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of <=2.

OLPT2 consisted of all participants who were enrolled into the OL part 2 and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores:more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27,where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57,where higher scores:more disease activity.Inactive disease activity based on JADAS-27 CRP score was defined as: For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of:<=1.For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of <=1.

OLPT1 consisted of all participants who were enrolled into the OL part 1 and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores:more inflammation and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive Disease activity based on JADAS-27 ESR score was defined as for participants with polyarthritis(>4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of:<=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of <=1.

OLPT1 consisted of all participants who were enrolled into the OL part 1 and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA.Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores: more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27,where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57,where higher scores: more disease activity.Inactive disease activity based on JADAS-27 CRP score was defined as: For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of:<=1.For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of <=1.

OLPT2 consisted of all participants who were enrolled into the OL part 2 and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores:more inflammation and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive Disease activity based on JADAS-27 ESR score was defined as for participants with polyarthritis(>4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of:<=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of <=1.

OLPT2 consisted of all participants who were enrolled into the OL part 2 and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed": participants evaluable for specified time points and used for calculating percentages.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of: <= 3.8. For participants with oligoarthritis (<= 4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of <=2.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of: <= 3.8. For participants with oligoarthritis (<= 4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of <=2.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

JADAS-27 is a validated composite disease activity measure for JIA.Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor),CRP (value normalized to 0 to 10 scale, where higher scores:more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity).The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive disease activity based on JADAS-27 CRP score was defined as: For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of:<=1.For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of <=1.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores:more inflammation and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive Disease activity based on JADAS-27 ESR score was defined as for participants with polyarthritis(>4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of:<=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of <=1.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.

The ACR clinical inactive disease was defined as follows: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA; no active uveitis; normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA; physician global assessment of disease activity score of 'best possible' on the 21-numbered circle VAS scale used (VAS from 0 to 10), higher scores indicated more disease activity; duration of morning stiffness of <=15 minutes. 95% CI was based on normal approximation.

OLPT1 consisted of all participants who were enrolled into the OL part 1 and received at least one dose of investigational product in part 1. Here "Number analyzed" signifies participants evaluable for specified time points and used for calculating percentages.

The ACR clinical inactive disease was defined as follows: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA; no active uveitis; normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA; physician global assessment of disease activity score of 'best possible' on the 21-numbered circle VAS scale used (VAS from 0 to 10), higher scores indicated more disease activity; duration of morning stiffness of <=15 minutes. 95% CI was based on normal approximation. 95% CI was based on normal approximation.

OLPT2 consisted of all participants who were enrolled into the OL part 2 and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here "Number analyzed" signifies participants evaluable for specified time points and used for calculating percentages

The ACR clinical inactive disease was defined as follows: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA; no active uveitis; normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA; physician global assessment of disease activity score of 'best possible' on the 21-numbered circle VAS scale used (VAS from 0 to 10), higher scores indicated more disease activity; duration of morning stiffness of <=15 minutes. 95% CI was based on normal approximation. 95% CI was based on normal approximation.

DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.