A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. An interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. If either criterion is met, the study will be stopped. If neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Treatment with investigational drug
Treatment with investigational drug or placebo
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Cohen Children's Medical Center of New York
Lake Success, New York, United States
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase
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.
Time frame: From randomization up to 248 weeks
Probability of Occurrence of sJIA Disease Flare at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: Double-Blind 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.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants Who Achieved Successful Corticosteroid Tapering: at the End of Open-label Phase Part 2
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.
Time frame: From end of OL Part 1 to up to 24 weeks in OL Part 2
Percentage of Participants Who Achieved Corticosteroid Dose of <= 0.2 mg/kg/Day or 10 mg/Day: at the End of Open-label Phase Part 2
95% CI was based on normal approximation.
Time frame: From end of OL Part 1 to up to 24 weeks in OL Part 2
Percentage of Participants With Adapted JIA ACR 30/50/70/90/100 Response at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind 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).Missing response was imputed as non-response.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants With Adapted JIA American College of Rheumatology (ACR) 30/50/70/90/100 Response at Part 1 Day 7, Weeks 2, 4, 8, 12, and 16: Open-Label Phase Part 1
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).
Time frame: Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, and 16
Percentage of Participants With Adapted JIA ACR 30/50/70/90/100 Response at Part 2 Weeks 4, 8, 12, 16, 20 and 24: Open-label Phase 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).
Time frame: Part 2 Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1
Fever was defined as an oral temperature of ˃38 degree Celsius/100.4 degree Fahrenheit. 95% CI was based on normal approximation.
Time frame: Part 1 Days 3, 7 and 14
Percentage of Participants With C-Reactive Protein (CRP) <= 10 mg/L at Baseline, Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Percentage of participants with CRP \<= 10 milligrams per liter (mg/L) along with 95% CI based on normal approximation is reported in this outcome.
Time frame: Baseline (last value collected prior to Day 1 of study treatment), Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16
Percentage of Participants With C-Reactive Protein (CRP) <= 10 mg/L at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-label Phase Part 2
Percentage of participants with CRP \<= 10 mg/L along with 95% CI based on normal approximation is reported in this outcome.
Time frame: Part 2 Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants With Absence of Fever Due to sJIA at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
Percentage of participants with absence of fever along with 95% CI based on normal approximation is reported in this outcome.
Time frame: Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, 16
Percentage of Participants With Absence of Fever Due to sJIA at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Percentage of participants with absence of fever along with 95% CI based on normal approximation is reported in this outcome.
Time frame: Part 2 Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With Absence of Fever Due to sJIA at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: Double Blind Phase
Percentage of participants with absence of fever due sJIA is reported in this outcome. Missing response was imputed as non-response.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Time to First Adapted JIA ACR 30 Response: Open-label Phase Part 1
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.
Time frame: From Day 1 up to 16 weeks
Change From Open Label Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) Erythrocyte Sedimentation Rate (ESR) at Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16: Open-Label Phase 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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16
Change From Open-Label Baseline in JADAS-27 CRP at Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16
Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24
Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24
Change From Double-Blind Baseline in JADAS-27 ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB Baseline (at randomization on Day 1 in DB phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Double-Blind Baseline in JADAS-27 CRP at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB Baseline (at randomization on Day 1 in DB phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24
Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
ESR was determined using an ESR testing kit.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16
Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
ESR was determined using an ESR testing kit.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Days 3,7, Part 1 Weeks 2, 4, 8, 12, 16
Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24
Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16
Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: OL baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB Baseline (values at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: OL label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
ESR was determined using an ESR testing kit.
Time frame: OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
ESR was determined using an ESR testing kit.
Time frame: DB Baseline (values at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: OL label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB Baseline (value at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
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.
Time frame: OL Baseline up to 16 weeks
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) up to 24 weeks
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
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.
Time frame: DB Baseline (values at randomization), DB Weeks 24, 48
Change From Open-Label Baseline in CHAQ-Discomfort Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
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.
Time frame: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 1 Day 7, Weeks 2, 4, 8, 12, 16
Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 2 Weeks 4, 8, 12, 16, 20, 24
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
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.
Time frame: DB Baseline (value at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
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.
Time frame: Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
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.
Time frame: Part 1 Day 7, Weeks 2, 4, 8, 12 and 16
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Part 2 Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Part 2 Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
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.
Time frame: Part 1 Day 7, Weeks 2, 4, 8, 12 and 16
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
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.
Time frame: Part 1 Day 7, Weeks 2, 4, 8, 12 and 16
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Part 2 Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Part 2 Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind 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.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind 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.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind 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.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind 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.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
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.
Time frame: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16
Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
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.
Time frame: Part 2 Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind 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. 95% CI was based on normal approximation.
Time frame: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Instituto CAICI SRL
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Universitair Ziekenhuis Gent
Ghent, Belgium
Faculdade de Medicina da UNESP
Botucatu, São Paulo, Brazil
UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP
Botucatu, São Paulo, Brazil
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