Arthritis Juvenile Idiopathic
Conditions
Keywords
systemic Juvenile Idiopathic Arthritis, Xeljanz, Tofacitinib, sJIA, CP-690 550
Brief summary
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.
Interventions
DRUGIn open-label phase: treatment with tofacitinib
Treatment with investigational drug
DRUGIn double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Treatment with investigational drug or placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* active sJIA disease according to ILAR criteria before screening and at baseline (Day 1); * Treatment with stable doses of methotrexate (MTX) ≤25 mg/week or ≤20 mg/m2/week, whichever is lower, is permitted; * Treatment with a stable dose of oral prednisone ≤1 mg/kg/day up to a maximum of 30 mg/day, or equivalent, for at least 1 week before the first study drug dose is permitted.
Exclusion criteria
* Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib. * Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with systemic juvenile idiopathic arthritis (sJIA). Current symptoms or findings of more than minimal pleuritis with sJIA. * Current infection or serious infection within 3 months of study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase | From randomization up to 248 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Successful Corticosteroid Tapering: at the End of Open-label Phase Part 2 | From end of OL Part 1 to up to 24 weeks in OL 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. |
| 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 | From end of OL Part 1 to up to 24 weeks in OL Part 2 | 95% CI was based on normal approximation. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, and 16 | 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). |
| 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 | Part 2 Weeks 4, 8, 12, 16, 20 and 24 | 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). |
| Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1 | Part 1 Days 3, 7 and 14 | Fever was defined as an oral temperature of ˃38 degree Celsius/100.4 degree Fahrenheit. 95% CI was based on normal approximation. |
| 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 | 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 CRP \<= 10 milligrams per liter (mg/L) along with 95% CI based on normal approximation is reported in this outcome. |
| 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 | Part 2 Weeks 4, 8, 12, 16, 20, 24 | Percentage of participants with CRP \<= 10 mg/L along with 95% CI based on normal approximation is reported in this outcome. |
| 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 | Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, 16 | Percentage of participants with absence of fever along with 95% CI based on normal approximation is reported in this outcome. |
| 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 | Part 2 Weeks 4, 8, 12, 16, 20 and 24 | Percentage of participants with absence of fever along with 95% CI based on normal approximation is reported in this outcome. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Percentage of participants with absence of fever due sJIA is reported in this outcome. Missing response was imputed as non-response. |
| Time to First Adapted JIA ACR 30 Response: Open-label Phase Part 1 | From Day 1 up to 16 weeks | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| 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 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16 | 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. |
| 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 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16 | 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. |
| 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 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16 | ESR was determined using an ESR testing kit. |
| Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24 | ESR was determined using an ESR testing kit. |
| 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 | 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 | 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. |
| 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 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16 | 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. |
| Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | 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 | 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. |
| 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 | DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | 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 | 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. |
| 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 | DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | 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 | 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. |
| 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 | DB Baseline (values at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | 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. |
| 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 | 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 | ESR was determined using an ESR testing kit. |
| 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 | DB Baseline (values at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | ESR was determined using an ESR testing kit. |
| 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 | 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 | 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. |
| 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 | DB Baseline (value at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | OL Baseline up to 16 weeks | 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. |
| Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) up to 24 weeks | 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. |
| Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | DB Baseline (values at randomization), DB Weeks 24, 48 | 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. |
| 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 | Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 1 Day 7, Weeks 2, 4, 8, 12, 16 | 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. |
| Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | DB Baseline (value at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16 | 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. |
| 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 | Part 1 Day 7, Weeks 2, 4, 8, 12 and 16 | 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. |
| 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 | Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | Part 1 Day 7, Weeks 2, 4, 8, 12 and 16 | 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. |
| 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 | Part 1 Day 7, Weeks 2, 4, 8, 12 and 16 | 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. |
| 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 | Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 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. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 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. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 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. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 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. |
| 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 | 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 | 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. |
| Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | Part 2 Weeks 4, 8, 12, 16, 20, 24 | 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. |
Countries
Argentina, Belgium, Brazil, Canada, China, Costa Rica, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Russia, South Africa, Spain, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
Participants who were diagnosed with Systemic Juvenile Idiopathic Arthritis (sJIA) with active systemic features were enrolled.
Pre-assignment details
A total of 168 participants were screened, of which 68 failed screening and only 100 participants were enrolled in open label part 1 (OLP1). From the total of 100 participants enrolled into OLP1 of the study, 54 participants were treated in open label part 2 (OLP2), and 59 participants were randomized between the treatment groups in the double-blinded (DB) phase.
Participants by arm
| Arm | Count |
|---|---|
| Overall All participants who received at least one dose of investigational product in the study. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double Blind Phase | Adverse Event | 0 | 0 | 2 | 1 |
| Double Blind Phase | Insufficient clinical response | 0 | 0 | 0 | 2 |
| Double Blind Phase | Other | 0 | 0 | 10 | 11 |
| Double Blind Phase | Withdrawal by parent/guardian | 0 | 0 | 2 | 0 |
| Open Label Part 1 | Adverse Event | 6 | 0 | 0 | 0 |
| Open Label Part 1 | Insufficient clinical response | 16 | 0 | 0 | 0 |
| Open Label Part 1 | Other | 2 | 0 | 0 | 0 |
| Open Label Part 2 | Insufficient clinical response | 0 | 12 | 0 | 0 |
| Open Label Part 2 | Other | 0 | 5 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Customized 12 to < 18 Years | 40 Participants |
| Age, Customized 2 to less than (<) 6 Years | 17 Participants |
| Age, Customized 6 to < 12 Years | 43 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 14 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 86 Participants |
| Race/Ethnicity, Customized Race Asian | 49 Participants |
| Race/Ethnicity, Customized Race Black or African American | 7 Participants |
| Race/Ethnicity, Customized Race Other | 5 Participants |
| Race/Ethnicity, Customized Race White | 39 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 54 | 0 / 28 | 0 / 31 |
| other Total, other adverse events | 33 / 100 | 15 / 54 | 23 / 28 | 25 / 31 |
| serious Total, serious adverse events | 7 / 100 | 0 / 54 | 0 / 28 | 2 / 31 |
Outcome results
Primary
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
Population: Double blind full analysis set (DBFAS) consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib 5mg BID DB | Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase | NA Days |
| Placebo DB | Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase | 295.0 Days |
p-value: =0.117195% CI: [0.296, 1.354]Unstratified log-rank test
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -0.08 Units on a scale | Standard Error 0.06 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -0.09 Units on a scale | Standard Error 0.07 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | -0.03 Units on a scale | Standard Error 0.06 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -0.06 Units on a scale | Standard Error 0.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 0.06 Units on a scale | Standard Error 0.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -0.03 Units on a scale | Standard Error 0.07 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 0.04 Units on a scale | Standard Error 0.06 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 0.02 Units on a scale | Standard Error 0.07 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 0.05 Units on a scale | Standard Error 0.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | -0.06 Units on a scale | Standard Error 0.06 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -0.03 Units on a scale | Standard Error 0.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -0.03 Units on a scale | Standard Error 0.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -0.05 Units on a scale | Standard Error 0.1 |
| Placebo DB | 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 | DB Week 36 | -0.19 Units on a scale | Standard Error 0.09 |
| Placebo DB | 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 | DB Week 12 | -0.05 Units on a scale | Standard Error 0.06 |
| Placebo DB | 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 | DB Week 16 | -0.05 Units on a scale | Standard Error 0.07 |
| Placebo DB | 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 | DB Week 20 | -0.23 Units on a scale | Standard Error 0.06 |
| Placebo DB | 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 | DB Week 24 | -0.09 Units on a scale | Standard Error 0.08 |
| Placebo DB | 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 | DB Week 32 | -0.13 Units on a scale | Standard Error 0.07 |
| Placebo DB | 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 | DB Week 4 | -0.02 Units on a scale | Standard Error 0.06 |
| Placebo DB | 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 | DB Week 40 | -0.25 Units on a scale | Standard Error 0.07 |
| Placebo DB | 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 | DB Week 48 | -0.19 Units on a scale | Standard Error 0.12 |
| Placebo DB | 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 | DB Week 52 | -0.21 Units on a scale | Standard Error 0.13 |
| Placebo DB | 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 | DB Week 8 | -0.01 Units on a scale | Standard Error 0.06 |
| Placebo DB | 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 | DB Week 28 | -0.04 Units on a scale | Standard Error 0.09 |
| Placebo DB | 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 | DB Week 44 | -0.10 Units on a scale | Standard Error 0.09 |
Comparison: DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.1, 0.24]
Comparison: DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.19, 0.15]
Comparison: DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.19, 0.16]
Comparison: DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.2, 0.23]
Comparison: DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.02, 0.32]
Comparison: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.09, 0.4]
Comparison: DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.16, 0.34]
Comparison: DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.05, 0.36]
Comparison: DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.1, 0.43]
Comparison: DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.06, 0.39]
Comparison: DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.22, 0.3]
Comparison: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.18, 0.49]
Comparison: DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.23, 0.55]
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 0.04 Units on a scale | Standard Error 0.34 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -0.31 Units on a scale | Standard Error 0.39 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 0.09 Units on a scale | Standard Error 0.4 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -0.55 Units on a scale | Standard Error 0.34 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 0.56 Units on a scale | Standard Error 0.36 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -0.76 Units on a scale | Standard Error 0.2 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 0.07 Units on a scale | Standard Error 0.27 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -1.09 Units on a scale | Standard Error 0.23 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 0.44 Units on a scale | Standard Error 0.36 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -0.19 Units on a scale | Standard Error 0.49 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -0.03 Units on a scale | Standard Error 0.47 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -0.85 Units on a scale | Standard Error 0.21 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 0.13 Units on a scale | Standard Error 0.28 |
| Placebo DB | 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 | DB Week 52 | -0.76 Units on a scale | Standard Error 0.34 |
| Placebo DB | 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 | DB Week 4 | 0.37 Units on a scale | Standard Error 0.26 |
| Placebo DB | 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 | DB Week 8 | 0.02 Units on a scale | Standard Error 0.35 |
| Placebo DB | 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 | DB Week 12 | 0.09 Units on a scale | Standard Error 0.32 |
| Placebo DB | 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 | DB Week 16 | -0.11 Units on a scale | Standard Error 0.35 |
| Placebo DB | 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 | DB Week 20 | -0.14 Units on a scale | Standard Error 0.42 |
| Placebo DB | 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 | DB Week 24 | -0.25 Units on a scale | Standard Error 0.28 |
| Placebo DB | 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 | DB Week 28 | 0.39 Units on a scale | Standard Error 0.51 |
| Placebo DB | 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 | DB Week 32 | 0.01 Units on a scale | Standard Error 0.42 |
| Placebo DB | 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 | DB Week 36 | -0.24 Units on a scale | Standard Error 0.37 |
| Placebo DB | 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 | DB Week 40 | -0.83 Units on a scale | Standard Error 0.21 |
| Placebo DB | 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 | DB Week 44 | -0.79 Units on a scale | Standard Error 0.24 |
| Placebo DB | 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 | DB Week 48 | -0.43 Units on a scale | Standard Error 0.79 |
Comparison: CHAQ-Discomfort Index at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.02, 0.54]
Comparison: CHAQ-Discomfort Index at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.49, 1.57]
Comparison: CHAQ-Discomfort Index at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.01, 0.9]
Comparison: CHAQ-Discomfort Index at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.49, 1.58]
Comparison: CHAQ-Discomfort Index at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.98, 1.45]
Comparison: CHAQ-Discomfort Index at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.51, 1.14]
Comparison: CHAQ-Discomfort Index at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.87, 1.03]
Comparison: CHAQ-Discomfort Index at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.53, 0.88]
Comparison: CHAQ-Discomfort Index at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.36, 0.74]
Comparison: CHAQ-Discomfort Index at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.55, 0.69]
Comparison: CHAQ-Discomfort Index at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.01, 0.39]
Comparison: CHAQ-Discomfort Index at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.45, 1.92]
Comparison: CHAQ-Discomfort Index at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.87, 0.69]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 0.54 Units on a scale | Standard Error 0.52 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -0.32 Units on a scale | Standard Error 0.24 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -0.56 Units on a scale | Standard Error 0.21 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -0.65 Units on a scale | Standard Error 0.24 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 0.46 Units on a scale | Standard Error 0.28 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 0.60 Units on a scale | Standard Error 0.38 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 0.25 Units on a scale | Standard Error 0.36 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 0.27 Units on a scale | Standard Error 0.31 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 0.14 Units on a scale | Standard Error 0.37 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 0.14 Units on a scale | Standard Error 0.29 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -0.72 Units on a scale | Standard Error 0.19 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -0.16 Units on a scale | Standard Error 0.36 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -0.82 Units on a scale | Standard Error 0.26 |
| Placebo DB | 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 | DB Week 48 | -0.37 Units on a scale | Standard Error 0.53 |
| Placebo DB | 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 | DB Week 28 | 0.52 Units on a scale | Standard Error 0.56 |
| Placebo DB | 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 | DB Week 16 | 0.04 Units on a scale | Standard Error 0.31 |
| Placebo DB | 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 | DB Week 32 | -0.34 Units on a scale | Standard Error 0.25 |
| Placebo DB | 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 | DB Week 40 | -0.78 Units on a scale | Standard Error 0.2 |
| Placebo DB | 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 | DB Week 20 | 0.05 Units on a scale | Standard Error 0.38 |
| Placebo DB | 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 | DB Week 44 | -0.54 Units on a scale | Standard Error 0.25 |
| Placebo DB | 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 | DB Week 52 | -0.87 Units on a scale | Standard Error 0.38 |
| Placebo DB | 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 | DB Week 4 | -0.03 Units on a scale | Standard Error 0.27 |
| Placebo DB | 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 | DB Week 24 | -0.14 Units on a scale | Standard Error 0.3 |
| Placebo DB | 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 | DB Week 8 | 0.12 Units on a scale | Standard Error 0.38 |
| Placebo DB | 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 | DB Week 36 | -0.63 Units on a scale | Standard Error 0.22 |
| Placebo DB | 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 | DB Week 12 | 0.22 Units on a scale | Standard Error 0.35 |
Comparison: DB at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.32, 1.3]
Comparison: DB at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.64, 1.61]
Comparison: DB at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.02, 1.07]
Comparison: DB at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.69, 1.14]
Comparison: DB at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.05, 1.22]
Comparison: DB at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.6, 1.16]
Comparison: DB at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.6, 1.64]
Comparison: DB at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.6, 1.64]
Comparison: DB at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.58, 0.73]
Comparison: DB at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.53, 0.65]
Comparison: DB at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.87, 0.64]
Comparison: DB at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.13, 1.54]
Comparison: DB at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1, 1.11]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Emotional Subscale Standardized Score: DB Week 24 | 2.62 Units on a scale | Standard Error 4 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Mental Health Subscale Standardized Score: DB Week 48 | 0.79 Units on a scale | Standard Error 4.98 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24 | -1.61 Units on a scale | Standard Error 4.19 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Self Esteem Subscale Standardized Score: DB Week 24 | 6.68 Units on a scale | Standard Error 3.05 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Physical Functioning Subscale Standardized Score: DB Week 24 | 2.51 Units on a scale | Standard Error 3.86 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Self Esteem Subscale Standardized Score: DB Week 48 | 3.05 Units on a scale | Standard Error 7.24 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48 | -2.72 Units on a scale | Standard Error 10.19 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-General Health Subscale Standardized Score: DB Week 24 | 5.02 Units on a scale | Standard Error 3.21 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Emotional Subscale Standardized Score: DB Week 48 | 6.09 Units on a scale | Standard Error 7.69 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-General Health Subscale Standardized Score: DB Week 48 | 9.59 Units on a scale | Standard Error 5.2 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Behavior Subscale Standardized Score: DB Week 24 | 2.33 Units on a scale | Standard Error 2.68 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Change in Health Subscale Score: DB Week 24 | 0.45 Units on a scale | Standard Error 0.12 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Health Subscale Standardized Score: DB Week 48 | 4.09 Units on a scale | Standard Error 3.93 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Change in Health Subscale Score: DB Week 48 | 0.64 Units on a scale | Standard Error 0.32 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Behavior Subscale Standardized Score: DB Week 48 | -4.50 Units on a scale | Standard Error 4.97 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Emotion al Impact on Parent Subscale Standardized Score: DB Week 24 | 15.00 Units on a scale | Standard Error 4.28 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Physical Subscale Standardized Score: DB Week 24 | 2.75 Units on a scale | Standard Error 4.27 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Emotion al Impact on Parent Subscale Standardized Score: DB Week 48 | 7.15 Units on a scale | Standard Error 10.25 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Behavior Subscale Standardized Score: DB Week 24 | 4.17 Units on a scale | Standard Error 3.89 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Time Impact on Parent Subscale Standardized Score: DB Week 24 | 7.53 Units on a scale | Standard Error 5.1 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Health Subscale Standardized Score: DB Week 24 | 4.02 Units on a scale | Standard Error 4.71 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Time Impact on Parent Subscale Standardized Score: DB Week 48 | 11.60 Units on a scale | Standard Error 8.94 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Behavior Subscale Standardized Score: DB Week 48 | 5.90 Units on a scale | Standard Error 4 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Activities Subscale Standardized Score: DB Week 24 | 5.71 Units on a scale | Standard Error 2.96 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Physical Subscale Standardized Score: DB Week 48 | 3.45 Units on a scale | Standard Error 13.33 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Activities Subscale Standardized Score: DB Week 48 | 6.65 Units on a scale | Standard Error 5.73 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Cohesion Subscale Standardized Score: DB Week 24 | 2.84 Units on a scale | Standard Error 3.71 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Mental Health Subscale Standardized Score: DB Week 24 | 6.59 Units on a scale | Standard Error 3.56 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Cohesion Subscale Standardized Score: DB Week 48 | -12.24 Units on a scale | Standard Error 13.08 |
| Tofacitinib 5mg BID DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Physical Functioning Subscale Standardized Score: DB Week 48 | 5.24 Units on a scale | Standard Error 9.13 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Cohesion Subscale Standardized Score: DB Week 48 | 8.18 Units on a scale | Standard Error 15.58 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Activities Subscale Standardized Score: DB Week 48 | 15.95 Units on a scale | Standard Error 7.16 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Health Subscale Standardized Score: DB Week 24 | -1.98 Units on a scale | Standard Error 5.02 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Health Subscale Standardized Score: DB Week 48 | 1.24 Units on a scale | Standard Error 4.49 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Physical Functioning Subscale Standardized Score: DB Week 24 | 6.70 Units on a scale | Standard Error 3.99 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Physical Functioning Subscale Standardized Score: DB Week 48 | 2.93 Units on a scale | Standard Error 14.02 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Emotional Subscale Standardized Score: DB Week 24 | 8.09 Units on a scale | Standard Error 4.18 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Emotional Subscale Standardized Score: DB Week 48 | -0.73 Units on a scale | Standard Error 10.33 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Physical Subscale Standardized Score: DB Week 24 | 8.98 Units on a scale | Standard Error 4.54 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Social Limitations: Physical Subscale Standardized Score: DB Week 48 | -7.64 Units on a scale | Standard Error 20.06 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24 | -0.16 Units on a scale | Standard Error 4.41 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48 | -19.92 Units on a scale | Standard Error 13.98 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Behavior Subscale Standardized Score: DB Week 24 | 7.48 Units on a scale | Standard Error 2.87 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Behavior Subscale Standardized Score: DB Week 48 | 10.53 Units on a scale | Standard Error 5.35 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Behavior Subscale Standardized Score: DB Week 24 | 9.48 Units on a scale | Standard Error 4.13 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Global Behavior Subscale Standardized Score: DB Week 48 | 13.14 Units on a scale | Standard Error 4.54 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Mental Health Subscale Standardized Score: DB Week 24 | 2.14 Units on a scale | Standard Error 3.78 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Mental Health Subscale Standardized Score: DB Week 48 | 8.26 Units on a scale | Standard Error 5.71 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Self Esteem Subscale Standardized Score: DB Week 24 | 6.69 Units on a scale | Standard Error 3.24 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Self Esteem Subscale Standardized Score: DB Week 48 | 10.64 Units on a scale | Standard Error 8.04 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-General Health Subscale Standardized Score: DB Week 24 | 0.03 Units on a scale | Standard Error 3.42 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-General Health Subscale Standardized Score: DB Week 48 | 10.60 Units on a scale | Standard Error 5.92 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Change in Health Subscale Score: DB Week 24 | 0.48 Units on a scale | Standard Error 0.13 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Change in Health Subscale Score: DB Week 48 | 0.16 Units on a scale | Standard Error 0.35 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Emotion al Impact on Parent Subscale Standardized Score: DB Week 24 | 12.75 Units on a scale | Standard Error 4.53 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Emotion al Impact on Parent Subscale Standardized Score: DB Week 48 | 32.22 Units on a scale | Standard Error 11.79 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Time Impact on Parent Subscale Standardized Score: DB Week 24 | 5.66 Units on a scale | Standard Error 5.25 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Time Impact on Parent Subscale Standardized Score: DB Week 48 | 20.79 Units on a scale | Standard Error 14.05 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Activities Subscale Standardized Score: DB Week 24 | 9.68 Units on a scale | Standard Error 3.13 |
| Placebo DB | Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase | CHQ01-Family Cohesion Subscale Standardized Score: DB Week 24 | 6.36 Units on a scale | Standard Error 3.96 |
Comparison: CHQ01-Global Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-8.35, 20.36]
Comparison: CHQ01-Global Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-12.43, 18.14]
Comparison: CHQ01-Physical Functioning Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-15.78, 7.4]
Comparison: CHQ01-Physical Functioning Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-37.06, 41.68]
Comparison: CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-17.37, 6.43]
Comparison: CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-20.92, 34.57]
Comparison: CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-18.95, 6.5]
Comparison: CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-46.24, 68.42]
Comparison: CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-13.97, 11.06]
Comparison: CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-28.01, 62.41]
Comparison: CHQ01-Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-13.24, 2.93]
Comparison: CHQ01-Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-33.12, 3.06]
Comparison: CHQ01-Global Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-16.92, 6.29]
Comparison: CHQ01-Global Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-20.35, 5.87]
Comparison: CHQ01-Mental Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-6.18, 15.07]
Comparison: CHQ01-Mental Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-24.37, 9.45]
Comparison: CHQ01-Self Esteem Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-9.14, 9.13]
Comparison: CHQ01-Self Esteem Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-33.87, 18.7]
Comparison: CHQ01-General Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-4.81, 14.77]
Comparison: CHQ01-General Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-20.31, 18.28]
Comparison: CHQ01-Change in Health Subscale Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.4, 0.33]
Comparison: CHQ01-Change in Health Subscale Score; DB Week48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.68, 1.65]
Comparison: CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-10.59, 15.1]
Comparison: CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-60.96, 10.82]
Comparison: CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-13.55, 17.29]
Comparison: CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-48.91, 30.53]
Comparison: CHQ01-Family Activities Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-12.84, 4.9]
Comparison: CHQ01-Family Activities Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-32.35, 13.75]
Comparison: CHQ01-Family Cohesion Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-14.84, 7.81]
Comparison: CHQ01-Family Cohesion Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-79.03, 38.18]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 1.42 Millimeter/ hour (mm/h) | Standard Error 4.53 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 2.01 Millimeter/ hour (mm/h) | Standard Error 3.78 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -2.04 Millimeter/ hour (mm/h) | Standard Error 2.17 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 0.88 Millimeter/ hour (mm/h) | Standard Error 4.83 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 1.94 Millimeter/ hour (mm/h) | Standard Error 3.97 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 0.34 Millimeter/ hour (mm/h) | Standard Error 4.25 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -2.51 Millimeter/ hour (mm/h) | Standard Error 2.14 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -7.05 Millimeter/ hour (mm/h) | Standard Error 2.34 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 0.45 Millimeter/ hour (mm/h) | Standard Error 4.32 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -8.07 Millimeter/ hour (mm/h) | Standard Error 2.38 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 1.73 Millimeter/ hour (mm/h) | Standard Error 4.19 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -11.70 Millimeter/ hour (mm/h) | Standard Error 1.39 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 3.35 Millimeter/ hour (mm/h) | Standard Error 3.71 |
| Placebo DB | 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 | DB Week 52 | -9.14 Millimeter/ hour (mm/h) | Standard Error 1.73 |
| Placebo DB | 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 | DB Week 4 | 9.41 Millimeter/ hour (mm/h) | Standard Error 3.5 |
| Placebo DB | 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 | DB Week 8 | 12.39 Millimeter/ hour (mm/h) | Standard Error 3.93 |
| Placebo DB | 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 | DB Week 12 | 12.28 Millimeter/ hour (mm/h) | Standard Error 4.4 |
| Placebo DB | 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 | DB Week 16 | 13.59 Millimeter/ hour (mm/h) | Standard Error 4.35 |
| Placebo DB | 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 | DB Week 20 | 4.98 Millimeter/ hour (mm/h) | Standard Error 2.31 |
| Placebo DB | 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 | DB Week 24 | 2.01 Millimeter/ hour (mm/h) | Standard Error 2.28 |
| Placebo DB | 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 | DB Week 28 | 11.08 Millimeter/ hour (mm/h) | Standard Error 4.55 |
| Placebo DB | 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 | DB Week 32 | 8.77 Millimeter/ hour (mm/h) | Standard Error 4.05 |
| Placebo DB | 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 | DB Week 36 | 16.37 Millimeter/ hour (mm/h) | Standard Error 5.17 |
| Placebo DB | 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 | DB Week 40 | 8.33 Millimeter/ hour (mm/h) | Standard Error 4.47 |
| Placebo DB | 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 | DB Week 44 | 3.44 Millimeter/ hour (mm/h) | Standard Error 2.41 |
| Placebo DB | 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 | DB Week 48 | -2.14 Millimeter/ hour (mm/h) | Standard Error 2.96 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-16.3, 4.19]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-21.68, 0.77]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-23.75, 2.03]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-25.83, -0.46]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-13.56, -0.47]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-11, 1.95]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-22.24, 3.54]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-18.34, 4.83]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-30.36, -0.63]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-21, 5.03]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-17.67, -3.31]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-13.53, 1.67]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-6.37, 1.24]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 1.58 Units on a scale | Standard Error 1.04 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 0.84 Units on a scale | Standard Error 1.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 0.49 Units on a scale | Standard Error 0.99 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 2.64 Units on a scale | Standard Error 1.86 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -1.59 Units on a scale | Standard Error 0.5 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -0.17 Units on a scale | Standard Error 0.84 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 0.38 Units on a scale | Standard Error 1.15 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 2.12 Units on a scale | Standard Error 0.95 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -1.09 Units on a scale | Standard Error 0.99 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 1.78 Units on a scale | Standard Error 1.46 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -2.04 Units on a scale | Standard Error 0.51 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -2.31 Units on a scale | Standard Error 0.6 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 1.62 Units on a scale | Standard Error 0.96 |
| Placebo DB | 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 | DB Week 52 | -1.85 Units on a scale | Standard Error 1.1 |
| Placebo DB | 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 | DB Week 4 | 0.71 Units on a scale | Standard Error 0.9 |
| Placebo DB | 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 | DB Week 12 | 1.80 Units on a scale | Standard Error 1.4 |
| Placebo DB | 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 | DB Week 20 | 0.36 Units on a scale | Standard Error 0.87 |
| Placebo DB | 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 | DB Week 24 | -0.26 Units on a scale | Standard Error 1.08 |
| Placebo DB | 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 | DB Week 48 | -1.23 Units on a scale | Standard Error 0.76 |
| Placebo DB | 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 | DB Week 8 | 0.01 Units on a scale | Standard Error 0.93 |
| Placebo DB | 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 | DB Week 16 | 1.95 Units on a scale | Standard Error 1.08 |
| Placebo DB | 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 | DB Week 28 | 2.72 Units on a scale | Standard Error 2.04 |
| Placebo DB | 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 | DB Week 32 | 1.18 Units on a scale | Standard Error 1.07 |
| Placebo DB | 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 | DB Week 36 | -1.24 Units on a scale | Standard Error 0.53 |
| Placebo DB | 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 | DB Week 40 | 0.41 Units on a scale | Standard Error 1.21 |
| Placebo DB | 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 | DB Week 44 | 1.50 Units on a scale | Standard Error 1.02 |
Comparison: DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.8, 3.61]
Comparison: DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.64, 4.86]
Comparison: DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-4.25, 4.21]
Comparison: DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-4.32, 2.09]
Comparison: DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.04, 1.98]
Comparison: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.29, 4.97]
Comparison: DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-5.89, 5.72]
Comparison: DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.79, 2.41]
Comparison: DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.89, 1.19]
Comparison: DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.63, 3.58]
Comparison: DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-5.67, 0.49]
Comparison: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-2.82, 1.19]
Comparison: DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.27, 2.36]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -0.49 Units on a scale | Standard Error 0.57 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 1.07 Units on a scale | Standard Error 0.84 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -0.21 Units on a scale | Standard Error 0.77 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 1.75 Units on a scale | Standard Error 1.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -1.04 Units on a scale | Standard Error 0.65 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 1.47 Units on a scale | Standard Error 1.46 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -0.23 Units on a scale | Standard Error 0.91 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 0.43 Units on a scale | Standard Error 1.03 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -1.52 Units on a scale | Standard Error 0.5 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 2.58 Units on a scale | Standard Error 2.05 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -1.67 Units on a scale | Standard Error 0.75 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -2.29 Units on a scale | Standard Error 0.38 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -2.41 Units on a scale | Standard Error 0.6 |
| Placebo DB | 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 | DB Week 48 | -2.06 Units on a scale | Standard Error 0.6 |
| Placebo DB | 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 | DB Week 20 | 0.05 Units on a scale | Standard Error 0.69 |
| Placebo DB | 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 | DB Week 24 | -0.79 Units on a scale | Standard Error 0.6 |
| Placebo DB | 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 | DB Week 28 | 3.86 Units on a scale | Standard Error 2.25 |
| Placebo DB | 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 | DB Week 32 | -0.68 Units on a scale | Standard Error 0.83 |
| Placebo DB | 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 | DB Week 40 | -0.96 Units on a scale | Standard Error 0.96 |
| Placebo DB | 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 | DB Week 52 | -1.65 Units on a scale | Standard Error 1.07 |
| Placebo DB | 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 | DB Week 4 | 1.08 Units on a scale | Standard Error 0.79 |
| Placebo DB | 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 | DB Week 8 | 0.81 Units on a scale | Standard Error 1.06 |
| Placebo DB | 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 | DB Week 12 | 1.71 Units on a scale | Standard Error 1.4 |
| Placebo DB | 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 | DB Week 36 | -1.26 Units on a scale | Standard Error 0.54 |
| Placebo DB | 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 | DB Week 44 | -0.83 Units on a scale | Standard Error 0.79 |
| Placebo DB | 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 | DB Week 16 | 1.29 Units on a scale | Standard Error 1.04 |
Comparison: DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-2.4, 2.38]
Comparison: DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-2.25, 4.12]
Comparison: DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-4.54, 4.06]
Comparison: DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.99, 2.28]
Comparison: DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.12, 0.94]
Comparison: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.46, 2.06]
Comparison: DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-7.85, 5.29]
Comparison: DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.98, 2.93]
Comparison: DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.86, 1.35]
Comparison: DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-2.18, 3.63]
Comparison: DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.22, 1.56]
Comparison: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.76, 1.3]
Comparison: DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-3.43, 1.93]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 1.47 Joints | Standard Error 0.85 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 0.31 Joints | Standard Error 0.25 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -0.15 Joints | Standard Error 0.15 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 0.01 Joints | Standard Error 0.18 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 0.78 Joints | Standard Error 0.38 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -0.14 Joints | Standard Error 0.15 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -0.06 Joints | Standard Error 0.12 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -0.05 Joints | Standard Error 0.35 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 0.05 Joints | Standard Error 0.27 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -0.20 Joints | Standard Error 0.21 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 0.71 Joints | Standard Error 0.7 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -0.14 Joints | Standard Error 0.28 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 0.38 Joints | Standard Error 0.26 |
| Placebo DB | 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 | DB Week 52 | -0.38 Joints | Standard Error 0.34 |
| Placebo DB | 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 | DB Week 4 | 0.09 Joints | Standard Error 0.24 |
| Placebo DB | 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 | DB Week 8 | -0.23 Joints | Standard Error 0.37 |
| Placebo DB | 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 | DB Week 12 | 0.22 Joints | Standard Error 0.81 |
| Placebo DB | 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 | DB Week 16 | -0.05 Joints | Standard Error 0.27 |
| Placebo DB | 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 | DB Week 20 | -0.02 Joints | Standard Error 0.17 |
| Placebo DB | 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 | DB Week 24 | -0.39 Joints | Standard Error 0.13 |
| Placebo DB | 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 | DB Week 28 | 0.88 Joints | Standard Error 0.84 |
| Placebo DB | 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 | DB Week 40 | -0.37 Joints | Standard Error 0.28 |
| Placebo DB | 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 | DB Week 32 | -0.41 Joints | Standard Error 0.2 |
| Placebo DB | 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 | DB Week 36 | -0.47 Joints | Standard Error 0.17 |
| Placebo DB | 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 | DB Week 44 | 0.11 Joints | Standard Error 0.38 |
| Placebo DB | 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 | DB Week 48 | -0.56 Joints | Standard Error 0.27 |
Comparison: DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.43, 1]
Comparison: DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.06, 2.08]
Comparison: DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.13, 3.64]
Comparison: DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.68, 0.88]
Comparison: DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.58, 0.33]
Comparison: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.03, 0.68]
Comparison: DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-2.42, 2.08]
Comparison: DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.14, 0.97]
Comparison: DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.15, 0.79]
Comparison: DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.14, 1.49]
Comparison: DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.28, 0.96]
Comparison: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.43, 1.16]
Comparison: DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.82, 1.3]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -0.21 Joints | Standard Error 0.31 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -0.48 Joints | Standard Error 0.15 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 0.08 Joints | Standard Error 0.22 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 0.45 Joints | Standard Error 0.42 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 0.48 Joints | Standard Error 0.44 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -0.30 Joints | Standard Error 0.17 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -0.36 Joints | Standard Error 0.1 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -0.53 Joints | Standard Error 0.1 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -0.05 Joints | Standard Error 0.4 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -0.41 Joints | Standard Error 0.1 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -0.48 Joints | Standard Error 0.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -0.47 Joints | Standard Error 0.16 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -0.50 Joints | Standard Error 0.2 |
| Placebo DB | 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 | DB Week 40 | -0.43 Joints | Standard Error 0.17 |
| Placebo DB | 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 | DB Week 24 | -0.22 Joints | Standard Error 0.11 |
| Placebo DB | 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 | DB Week 52 | -0.42 Joints | Standard Error 0.33 |
| Placebo DB | 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 | DB Week 48 | -0.47 Joints | Standard Error 0.24 |
| Placebo DB | 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 | DB Week 4 | 0.21 Joints | Standard Error 0.2 |
| Placebo DB | 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 | DB Week 28 | 1.05 Joints | Standard Error 0.46 |
| Placebo DB | 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 | DB Week 8 | 0.06 Joints | Standard Error 0.42 |
| Placebo DB | 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 | DB Week 44 | -0.43 Joints | Standard Error 0.17 |
| Placebo DB | 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 | DB Week 12 | -0.23 Joints | Standard Error 0.42 |
| Placebo DB | 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 | DB Week 32 | -0.48 Joints | Standard Error 0.12 |
| Placebo DB | 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 | DB Week 16 | 0.10 Joints | Standard Error 0.17 |
| Placebo DB | 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 | DB Week 36 | -0.46 Joints | Standard Error 0.1 |
| Placebo DB | 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 | DB Week 20 | -0.19 Joints | Standard Error 0.11 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.73, 0.47]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.81, 1.59]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.54, 1.95]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.9, 0.1]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.46, 0.13]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.63, -0.01]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-2.34, 0.15]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.26, 0.4]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.3, 0.26]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.53, 0.43]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.56, 0.46]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.74, 0.69]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.91, 1.32]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 0.45 Units on a scale | Standard Error 0.32 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 0.09 Units on a scale | Standard Error 0.43 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -0.11 Units on a scale | Standard Error 0.34 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -0.11 Units on a scale | Standard Error 0.29 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 0.10 Units on a scale | Standard Error 0.4 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -0.74 Units on a scale | Standard Error 0.17 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 0.16 Units on a scale | Standard Error 0.25 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -0.17 Units on a scale | Standard Error 0.35 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -0.51 Units on a scale | Standard Error 0.22 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -0.79 Units on a scale | Standard Error 0.21 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -1.03 Units on a scale | Standard Error 0.2 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -1.00 Units on a scale | Standard Error 0.27 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -0.32 Units on a scale | Standard Error 0.22 |
| Placebo DB | 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 | DB Week 52 | -0.92 Units on a scale | Standard Error 0.39 |
| Placebo DB | 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 | DB Week 48 | -1.09 Units on a scale | Standard Error 0.29 |
| Placebo DB | 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 | DB Week 4 | 0.21 Units on a scale | Standard Error 0.24 |
| Placebo DB | 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 | DB Week 8 | -0.14 Units on a scale | Standard Error 0.32 |
| Placebo DB | 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 | DB Week 16 | 0.15 Units on a scale | Standard Error 0.34 |
| Placebo DB | 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 | DB Week 20 | -0.35 Units on a scale | Standard Error 0.23 |
| Placebo DB | 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 | DB Week 24 | -0.37 Units on a scale | Standard Error 0.22 |
| Placebo DB | 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 | DB Week 28 | 0.19 Units on a scale | Standard Error 0.47 |
| Placebo DB | 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 | DB Week 32 | -0.42 Units on a scale | Standard Error 0.32 |
| Placebo DB | 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 | DB Week 36 | -0.92 Units on a scale | Standard Error 0.18 |
| Placebo DB | 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 | DB Week 40 | -0.53 Units on a scale | Standard Error 0.37 |
| Placebo DB | 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 | DB Week 44 | -0.70 Units on a scale | Standard Error 0.22 |
| Placebo DB | 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 | DB Week 12 | -0.02 Units on a scale | Standard Error 0.39 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.77, 0.67]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.37, 1.53]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.06, 1.3]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.27, 0.74]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.83, 0.52]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.61, 0.71]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.45, 1.25]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.61, 1.23]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.34, 0.71]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.74, 1.46]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.75, 0.56]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-0.68, 0.81]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.95% CI: [-1.1, 0.94]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -0.94 Units on a scale | Standard Error 0.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -1.01 Units on a scale | Standard Error 0.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -0.95 Units on a scale | Standard Error 0.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | -0.81 Units on a scale | Standard Error 0.1 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -0.94 Units on a scale | Standard Error 0.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | -0.99 Units on a scale | Standard Error 0.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -1.02 Units on a scale | Standard Error 0.07 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -0.96 Units on a scale | Standard Error 0.07 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -1.07 Units on a scale | Standard Error 0.07 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | -0.93 Units on a scale | Standard Error 0.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -1.04 Units on a scale | Standard Error 0.09 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -1.04 Units on a scale | Standard Error 0.1 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -1.05 Units on a scale | Standard Error 0.08 |
| Placebo DB | 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 | DB Week 52 | -1.13 Units on a scale | Standard Error 0.12 |
| Placebo DB | 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 | DB Week 12 | -1.04 Units on a scale | Standard Error 0.07 |
| Placebo DB | 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 | DB Week 20 | -1.21 Units on a scale | Standard Error 0.07 |
| Placebo DB | 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 | DB Week 24 | -1.05 Units on a scale | Standard Error 0.08 |
| Placebo DB | 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 | DB Week 28 | -1.01 Units on a scale | Standard Error 0.09 |
| Placebo DB | 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 | DB Week 32 | -1.11 Units on a scale | Standard Error 0.07 |
| Placebo DB | 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 | DB Week 44 | -1.08 Units on a scale | Standard Error 0.09 |
| Placebo DB | 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 | DB Week 48 | -1.10 Units on a scale | Standard Error 0.11 |
| Placebo DB | 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 | DB Week 8 | -1.02 Units on a scale | Standard Error 0.08 |
| Placebo DB | 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 | DB Week 16 | -1.05 Units on a scale | Standard Error 0.09 |
| Placebo DB | 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 | DB Week 36 | -1.16 Units on a scale | Standard Error 0.09 |
| Placebo DB | 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 | DB Week 40 | -1.22 Units on a scale | Standard Error 0.08 |
| Placebo DB | 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 | DB Week 4 | -1.03 Units on a scale | Standard Error 0.09 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.07, 0.5]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.15, 0.32]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.17, 0.28]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.16, 0.36]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.01, 0.38]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.12, 0.35]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.18, 0.31]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.06, 0.37]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.14, 0.36]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.06, 0.38]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.22, 0.3]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.2, 0.38]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.95% CI: [-0.24, 0.42]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -0.38 Units on a scale | Standard Deviation 0.43 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -0.52 Units on a scale | Standard Deviation 0.56 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -0.59 Units on a scale | Standard Deviation 0.57 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -0.21 Units on a scale | Standard Deviation 0.35 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -0.51 Units on a scale | Standard Deviation 0.56 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -0.74 Units on a scale | Standard Deviation 0.73 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 4 | -0.79 Units on a scale | Standard Deviation 0.63 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 8 | -0.78 Units on a scale | Standard Deviation 0.76 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 12 | -0.85 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 20 | -0.93 Units on a scale | Standard Deviation 0.77 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 16 | -0.67 Units on a scale | Standard Deviation 0.74 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 24 | -0.96 Units on a scale | Standard Deviation 0.92 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -3.30 Units on a scale | Standard Deviation 2.45 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -3.57 Units on a scale | Standard Deviation 2.5 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -1.20 Units on a scale | Standard Deviation 1.77 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -1.87 Units on a scale | Standard Deviation 2.07 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -2.57 Units on a scale | Standard Deviation 2.14 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -3.69 Units on a scale | Standard Deviation 2.28 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 4 | -4.23 Units on a scale | Standard Deviation 3.14 |
| Tofacitinib 5mg BID DB | Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 8 | -4.38 Units on a scale | Standard Deviation 2.95 |
| Tofacitinib 5mg BID DB | Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 12 | -4.42 Units on a scale | Standard Deviation 3.26 |
| Tofacitinib 5mg BID DB | Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 16 | -4.48 Units on a scale | Standard Deviation 2.88 |
| Tofacitinib 5mg BID DB | Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 20 | -5.15 Units on a scale | Standard Deviation 3.52 |
| Tofacitinib 5mg BID DB | Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 24 | -6.00 Units on a scale | Standard Deviation 1.73 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | -4.97 Units on a scale | Standard Error 0.34 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -5.63 Units on a scale | Standard Error 0.18 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -5.19 Units on a scale | Standard Error 0.32 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -5.81 Units on a scale | Standard Error 0.18 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | -4.56 Units on a scale | Standard Error 0.36 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -5.98 Units on a scale | Standard Error 0.16 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -4.97 Units on a scale | Standard Error 0.29 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -5.95 Units on a scale | Standard Error 0.21 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -4.88 Units on a scale | Standard Error 0.29 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -5.45 Units on a scale | Standard Error 0.31 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -5.08 Units on a scale | Standard Error 0.44 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -6.06 Units on a scale | Standard Error 0.25 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | -4.31 Units on a scale | Standard Error 0.37 |
| Placebo DB | 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 | DB Week 52 | -5.98 Units on a scale | Standard Error 0.43 |
| Placebo DB | 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 | DB Week 4 | -5.52 Units on a scale | Standard Error 0.34 |
| Placebo DB | 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 | DB Week 8 | -5.38 Units on a scale | Standard Error 0.35 |
| Placebo DB | 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 | DB Week 12 | -5.28 Units on a scale | Standard Error 0.33 |
| Placebo DB | 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 | DB Week 16 | -5.46 Units on a scale | Standard Error 0.29 |
| Placebo DB | 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 | DB Week 20 | -5.36 Units on a scale | Standard Error 0.34 |
| Placebo DB | 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 | DB Week 24 | -5.62 Units on a scale | Standard Error 0.3 |
| Placebo DB | 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 | DB Week 28 | -5.00 Units on a scale | Standard Error 0.48 |
| Placebo DB | 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 | DB Week 32 | -5.55 Units on a scale | Standard Error 0.2 |
| Placebo DB | 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 | DB Week 36 | -5.87 Units on a scale | Standard Error 0.21 |
| Placebo DB | 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 | DB Week 40 | -5.94 Units on a scale | Standard Error 0.18 |
| Placebo DB | 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 | DB Week 44 | -5.79 Units on a scale | Standard Error 0.23 |
| Placebo DB | 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 | DB Week 48 | -5.30 Units on a scale | Standard Error 0.57 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [0.2, 2.22]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.2, 1.85]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.65, 1.27]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.26, 1.41]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.78, 1.1]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.18, 1.49]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-1.43, 1.27]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.65, 0.5]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.51, 0.63]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.55, 0.47]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.82, 0.5]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-1.51, 1.22]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-1.05, 0.88]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -1.36 Units on a scale | Standard Deviation 1.91 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -1.96 Units on a scale | Standard Deviation 1.89 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -2.65 Units on a scale | Standard Deviation 2.44 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -3.35 Units on a scale | Standard Deviation 2.38 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -3.45 Units on a scale | Standard Deviation 2.45 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -3.48 Units on a scale | Standard Deviation 2.78 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 3 | -0.73 Units on a scale | Standard Deviation 1.53 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | -5.11 Units on a scale | Standard Deviation 2.5 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | -5.65 Units on a scale | Standard Deviation 2.89 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | -6.33 Units on a scale | Standard Deviation 2.31 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | -4.09 Units on a scale | Standard Deviation 2.68 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | -4.50 Units on a scale | Standard Deviation 2.88 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | -4.73 Units on a scale | Standard Deviation 2.83 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Global Health Subscale Standardized Score | 26.12 Units on a scale | Standard Deviation 29.1 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Physical Functioning Subscale Standardized Score | 28.95 Units on a scale | Standard Deviation 33.79 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Social Limitations: Emotional Subscale Standardized Score | 27.51 Units on a scale | Standard Deviation 38.39 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Social Limitations: Physical Subscale Standardized Score | 31.15 Units on a scale | Standard Deviation 42.96 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Bodily Pain Subscale Standardized Score | 32.00 Units on a scale | Standard Deviation 26.67 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Behavior Subscale Standardized Score | 10.98 Units on a scale | Standard Deviation 17.14 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Global Behavior Subscale Standardized Score | 11.18 Units on a scale | Standard Deviation 27.75 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Mental Health Subscale Standardized Score | 13.33 Units on a scale | Standard Deviation 20.2 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Self Esteem Subscale Standardized Score | 7.68 Units on a scale | Standard Deviation 21.29 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | General Health Subscale Standardized Score | 8.37 Units on a scale | Standard Deviation 13.93 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Change in Health Subscale Score | 1.28 Units on a scale | Standard Deviation 1.1 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Emotional Impact on Parent Subscale Standardized Score | 12.75 Units on a scale | Standard Deviation 26.43 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Time Impact on Parent Subscale Standardized Score | 14.81 Units on a scale | Standard Deviation 28.62 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Family Activities Subscale Standardized Score | 74.03 Units on a scale | Standard Deviation 22.41 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1 | Family Cohesion Subscale Standardized Score | 8.10 Units on a scale | Standard Deviation 22.67 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Global Health Standardized Score | 25.52 Units on a scale | Standard Deviation 35.46 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Physical Functioning Standardized Score | 33.33 Units on a scale | Standard Deviation 31.29 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Social Limitations: Emotional Score | 28.17 Units on a scale | Standard Deviation 43.98 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Social Limitations: Physical Score | 38.10 Units on a scale | Standard Deviation 42.28 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Bodily Pain Standardized Score | 34.48 Units on a scale | Standard Deviation 26.8 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Behavior Standardized Score | 13.02 Units on a scale | Standard Deviation 21.14 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Global Behavior Standardized Score | 10.00 Units on a scale | Standard Deviation 34.1 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Mental Health Standardized Score | 18.04 Units on a scale | Standard Deviation 21.01 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Self Esteem Standardized Score | 8.30 Units on a scale | Standard Deviation 34.18 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | General Health Standardized Score | 8.18 Units on a scale | Standard Deviation 15.94 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Change in Health Subscale Score | 1.54 Units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Emotional Impact on Parent Standardized Score | 22.92 Units on a scale | Standard Deviation 36.33 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Time Impact on Parent Standardized Score | 34.57 Units on a scale | Standard Deviation 25.66 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Family Activities Standardized Score | 27.62 Units on a scale | Standard Deviation 25.87 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2 | Family Cohesion Standardized Score | 10.00 Units on a scale | Standard Deviation 23.25 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | -38.30 Millimeter per hour (mm/h) | Standard Error 4.5 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -37.90 Millimeter per hour (mm/h) | Standard Error 3.67 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -41.82 Millimeter per hour (mm/h) | Standard Error 2.22 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -39.36 Millimeter per hour (mm/h) | Standard Error 4.49 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | -36.55 Millimeter per hour (mm/h) | Standard Error 4.38 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -39.98 Millimeter per hour (mm/h) | Standard Error 4.12 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -42.25 Millimeter per hour (mm/h) | Standard Error 2.25 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -47.16 Millimeter per hour (mm/h) | Standard Error 2.28 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -39.52 Millimeter per hour (mm/h) | Standard Error 4.06 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -47.16 Millimeter per hour (mm/h) | Standard Error 2.29 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -37.83 Millimeter per hour (mm/h) | Standard Error 4.07 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -51.46 Millimeter per hour (mm/h) | Standard Error 1.08 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | -32.65 Millimeter per hour (mm/h) | Standard Error 4.72 |
| Placebo DB | 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 | DB Week 52 | -50.12 Millimeter per hour (mm/h) | Standard Error 1.24 |
| Placebo DB | 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 | DB Week 4 | -31.19 Millimeter per hour (mm/h) | Standard Error 4.49 |
| Placebo DB | 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 | DB Week 8 | -29.32 Millimeter per hour (mm/h) | Standard Error 4.29 |
| Placebo DB | 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 | DB Week 12 | -31.69 Millimeter per hour (mm/h) | Standard Error 4.35 |
| Placebo DB | 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 | DB Week 16 | -31.02 Millimeter per hour (mm/h) | Standard Error 4.06 |
| Placebo DB | 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 | DB Week 20 | -37.86 Millimeter per hour (mm/h) | Standard Error 2.32 |
| Placebo DB | 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 | DB Week 24 | -40.81 Millimeter per hour (mm/h) | Standard Error 2.33 |
| Placebo DB | 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 | DB Week 28 | -33.51 Millimeter per hour (mm/h) | Standard Error 4.39 |
| Placebo DB | 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 | DB Week 32 | -35.04 Millimeter per hour (mm/h) | Standard Error 3.91 |
| Placebo DB | 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 | DB Week 36 | -28.41 Millimeter per hour (mm/h) | Standard Error 4.79 |
| Placebo DB | 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 | DB Week 40 | -35.70 Millimeter per hour (mm/h) | Standard Error 4.31 |
| Placebo DB | 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 | DB Week 44 | -38.84 Millimeter per hour (mm/h) | Standard Error 2.34 |
| Placebo DB | 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 | DB Week 48 | -42.32 Millimeter per hour (mm/h) | Standard Error 2.72 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-14.59, 11.66]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-19.62, 5.17]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-19.36, 6.14]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-20.28, 3.27]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-10.53, 2.62]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-8.09, 5.21]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-16.67, 8.03]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-13.97, 8.25]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-24.63, 2.73]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-16.74, 8.18]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-15.2, -1.43]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-12.6, 2.92]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-5.16, 2.48]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Part 1 Week 12 | -31.74 Millimeter per hour | Standard Deviation 21.75 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Part 1 Week 16 | -27.65 Millimeter per hour | Standard Deviation 28.84 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Part 1 Day 7 | -11.00 Millimeter per hour | Standard Deviation 16.96 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Part 1 Week 2 | -18.60 Millimeter per hour | Standard Deviation 19.78 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Part 1 Week 4 | -24.70 Millimeter per hour | Standard Deviation 23.86 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Part 1 Week 8 | -30.59 Millimeter per hour | Standard Deviation 23.12 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 4 | -33.64 Millimeter per hour | Standard Deviation 28.16 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 8 | -30.73 Millimeter per hour | Standard Deviation 27.11 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 12 | -27.52 Millimeter per hour | Standard Deviation 28.13 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 16 | -23.48 Millimeter per hour | Standard Deviation 24.7 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 20 | -37.54 Millimeter per hour | Standard Deviation 20.93 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 24 | -24.33 Millimeter per hour | Standard Deviation 6.03 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -13.10 Units on a scale | Standard Deviation 6.37 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -6.25 Units on a scale | Standard Deviation 5.53 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -8.55 Units on a scale | Standard Deviation 6.1 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -11.88 Units on a scale | Standard Deviation 7.28 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -15.07 Units on a scale | Standard Deviation 8.46 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -15.19 Units on a scale | Standard Deviation 7.73 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 8 | -17.44 Units on a scale | Standard Deviation 8.03 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 12 | -18.99 Units on a scale | Standard Deviation 7.67 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 20 | -22.16 Units on a scale | Standard Deviation 7.05 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 4 | -17.16 Units on a scale | Standard Deviation 8.87 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 16 | -20.31 Units on a scale | Standard Deviation 6.41 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 24 | -25.61 Units on a scale | Standard Deviation 9.82 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 4 | -17.05 Units on a scale | Standard Deviation 8.18 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 8 | -17.13 Units on a scale | Standard Deviation 8.14 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 16 | -18.89 Units on a scale | Standard Deviation 7.56 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 20 | -21.14 Units on a scale | Standard Deviation 5.78 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 12 | -18.17 Units on a scale | Standard Deviation 7.74 |
| Tofacitinib 5mg BID DB | Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 24 | -22.17 Units on a scale | Standard Deviation 7.58 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -5.64 Units on a scale | Standard Deviation 5.2 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -8.57 Units on a scale | Standard Deviation 5.97 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -11.95 Units on a scale | Standard Deviation 6.53 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -15.77 Units on a scale | Standard Deviation 7.24 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -15.09 Units on a scale | Standard Deviation 7.27 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -14.08 Units on a scale | Standard Deviation 6.09 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -7.34 Joints | Standard Error 0.25 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -7.06 Joints | Standard Error 0.24 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -7.41 Joints | Standard Error 0.18 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | -6.53 Joints | Standard Error 0.34 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -7.33 Joints | Standard Error 0.13 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -7.27 Joints | Standard Error 0.17 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -6.36 Joints | Standard Error 0.59 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -7.43 Joints | Standard Error 0.14 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | -6.36 Joints | Standard Error 0.38 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -7.54 Joints | Standard Error 0.2 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | -5.92 Joints | Standard Error 0.8 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -7.46 Joints | Standard Error 0.26 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -7.39 Joints | Standard Error 0.33 |
| Placebo DB | 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 | DB Week 52 | -7.51 Joints | Standard Error 0.28 |
| Placebo DB | 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 | DB Week 28 | -6.56 Joints | Standard Error 0.67 |
| Placebo DB | 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 | DB Week 32 | -7.76 Joints | Standard Error 0.19 |
| Placebo DB | 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 | DB Week 40 | -7.58 Joints | Standard Error 0.27 |
| Placebo DB | 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 | DB Week 44 | -7.20 Joints | Standard Error 0.35 |
| Placebo DB | 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 | DB Week 4 | -7.39 Joints | Standard Error 0.32 |
| Placebo DB | 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 | DB Week 12 | -7.36 Joints | Standard Error 0.76 |
| Placebo DB | 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 | DB Week 16 | -7.37 Joints | Standard Error 0.25 |
| Placebo DB | 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 | DB Week 20 | -7.51 Joints | Standard Error 0.2 |
| Placebo DB | 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 | DB Week 24 | -7.76 Joints | Standard Error 0.13 |
| Placebo DB | 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 | DB Week 36 | -7.78 Joints | Standard Error 0.16 |
| Placebo DB | 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 | DB Week 48 | -7.75 Joints | Standard Error 0.25 |
| Placebo DB | 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 | DB Week 8 | -7.69 Joints | Standard Error 0.38 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.08, 1.79]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [0.25, 2.4]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.79, 3.66]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.7, 0.74]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.43, 0.64]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [0.06, 0.81]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-1.64, 2.06]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.04, 1.03]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.09, 0.79]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.23, 1.28]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-1.2, 0.83]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.49, 0.91]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.95% CI: [-0.8, 0.92]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -6.03 Joints | Standard Deviation 6.04 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -7.80 Joints | Standard Deviation 9.25 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -7.52 Joints | Standard Deviation 7.38 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -6.38 Joints | Standard Deviation 7.87 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -2.96 Joints | Standard Deviation 4.17 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -4.21 Joints | Standard Deviation 5.31 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | -7.78 Joints | Standard Deviation 7.78 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | -7.73 Joints | Standard Deviation 8.4 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | -9.26 Joints | Standard Deviation 7.98 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | -10.00 Joints | Standard Deviation 7.99 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | -10.85 Joints | Standard Deviation 7.83 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | -13.67 Joints | Standard Deviation 11.02 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -2.98 Joints | Standard Error 0.19 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | -2.31 Joints | Standard Error 0.45 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -2.56 Joints | Standard Error 0.54 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -2.79 Joints | Standard Error 0.19 |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -2.89 Joints | Standard Error 0.18 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -2.76 Joints | Standard Error 0.44 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -2.90 Joints | Standard Error 0.19 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | -2.09 Joints | Standard Error 0.71 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -2.96 Joints | Standard Error 0.24 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -2.95 Joints | Standard Error 0.25 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -3.03 Joints | Standard Error 0.27 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -2.75 Joints | Standard Error 0.36 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | -2.47 Joints | Standard Error 0.43 |
| Placebo DB | 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 | DB Week 52 | -3.20 Joints | Standard Error 0.36 |
| Placebo DB | 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 | DB Week 12 | -3.29 Joints | Standard Error 0.68 |
| Placebo DB | 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 | DB Week 16 | -2.70 Joints | Standard Error 0.43 |
| Placebo DB | 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 | DB Week 20 | -3.05 Joints | Standard Error 0.19 |
| Placebo DB | 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 | DB Week 24 | -3.07 Joints | Standard Error 0.19 |
| Placebo DB | 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 | DB Week 4 | -2.69 Joints | Standard Error 0.41 |
| Placebo DB | 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 | DB Week 8 | -2.89 Joints | Standard Error 0.44 |
| Placebo DB | 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 | DB Week 44 | -3.24 Joints | Standard Error 0.26 |
| Placebo DB | 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 | DB Week 48 | -3.25 Joints | Standard Error 0.3 |
| Placebo DB | 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 | DB Week 28 | -2.10 Joints | Standard Error 0.56 |
| Placebo DB | 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 | DB Week 32 | -3.24 Joints | Standard Error 0.19 |
| Placebo DB | 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 | DB Week 36 | -3.21 Joints | Standard Error 0.21 |
| Placebo DB | 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 | DB Week 40 | -3.24 Joints | Standard Error 0.25 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.97, 1.4]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.68, 1.84]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.77, 3.16]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-1.3, 1.18]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.29, 0.82]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.46, 0.64]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-2.05, 1.13]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.18, 0.88]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.26, 0.88]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.43, 0.99]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.45, 1.03]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.63, 1.08]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.66, 1.57]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -1.83 Joints | Standard Deviation 4.26 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -2.06 Joints | Standard Deviation 4.7 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -2.90 Joints | Standard Deviation 5.42 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -4.36 Joints | Standard Deviation 8.59 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -3.64 Joints | Standard Deviation 6.05 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -2.33 Joints | Standard Deviation 3.48 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | -4.26 Joints | Standard Deviation 6.75 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | -3.90 Joints | Standard Deviation 6.08 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | -5.81 Joints | Standard Deviation 7.48 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | -5.74 Joints | Standard Deviation 7.13 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | -5.92 Joints | Standard Deviation 9.32 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | -15.67 Joints | Standard Deviation 11.02 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | -5.08 Units on a scale | Standard Error 0.26 |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | -4.22 Units on a scale | Standard Error 0.33 |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | -5.55 Units on a scale | Standard Error 0.16 |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | -4.89 Units on a scale | Standard Error 0.36 |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | -4.96 Units on a scale | Standard Error 0.32 |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | -5.23 Units on a scale | Standard Error 0.3 |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | -5.32 Units on a scale | Standard Error 0.23 |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | -5.65 Units on a scale | Standard Error 0.21 |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | -4.23 Units on a scale | Standard Error 0.32 |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | -5.87 Units on a scale | Standard Error 0.18 |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | -5.11 Units on a scale | Standard Error 0.22 |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | -5.86 Units on a scale | Standard Error 0.26 |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | -5.06 Units on a scale | Standard Error 0.37 |
| Placebo DB | 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 | DB Week 52 | -5.97 Units on a scale | Standard Error 0.33 |
| Placebo DB | 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 | DB Week 8 | -5.55 Units on a scale | Standard Error 0.32 |
| Placebo DB | 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 | DB Week 16 | -5.22 Units on a scale | Standard Error 0.32 |
| Placebo DB | 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 | DB Week 12 | -5.42 Units on a scale | Standard Error 0.34 |
| Placebo DB | 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 | DB Week 20 | -5.64 Units on a scale | Standard Error 0.24 |
| Placebo DB | 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 | DB Week 24 | -5.66 Units on a scale | Standard Error 0.23 |
| Placebo DB | 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 | DB Week 32 | -5.71 Units on a scale | Standard Error 0.28 |
| Placebo DB | 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 | DB Week 36 | -6.03 Units on a scale | Standard Error 0.18 |
| Placebo DB | 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 | DB Week 28 | -5.26 Units on a scale | Standard Error 0.4 |
| Placebo DB | 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 | DB Week 40 | -5.88 Units on a scale | Standard Error 0.33 |
| Placebo DB | 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 | DB Week 44 | -5.87 Units on a scale | Standard Error 0.22 |
| Placebo DB | 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 | DB Week 48 | -6.14 Units on a scale | Standard Error 0.24 |
| Placebo DB | 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 | DB Week 4 | -5.22 Units on a scale | Standard Error 0.32 |
Comparison: DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [0.09, 1.92]
Comparison: DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [0.4, 2.22]
Comparison: DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.47, 1.53]
Comparison: DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.63, 1.16]
Comparison: DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.33, 0.97]
Comparison: DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.1, 1.2]
Comparison: DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.93, 1.33]
Comparison: DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.17, 1.42]
Comparison: DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.02, 0.98]
Comparison: DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.3, 1.58]
Comparison: DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.4, 0.85]
Comparison: DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.36, 0.88]
Comparison: DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.95% CI: [-0.87, 1.09]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | -2.62 units on a scale | Standard Deviation 1.75 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | -3.40 units on a scale | Standard Deviation 2.01 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | -1.18 units on a scale | Standard Deviation 1.36 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | -1.82 units on a scale | Standard Deviation 1.68 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | -3.66 units on a scale | Standard Deviation 2.08 |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | -3.50 units on a scale | Standard Deviation 1.93 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | -4.54 Unit on a scale | Standard Deviation 2.1 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | -4.53 Unit on a scale | Standard Deviation 1.74 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | -4.65 Unit on a scale | Standard Deviation 1.57 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | -4.89 Unit on a scale | Standard Deviation 1.77 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | -5.62 Unit on a scale | Standard Deviation 1.21 |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | -6.17 Unit on a scale | Standard Deviation 1.44 |
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5mg BID DB | 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 | 59.26 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5mg BID DB | Percentage of Participants Who Achieved Successful Corticosteroid Tapering: at the End of Open-label Phase Part 2 | 70.37 Percentage of participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 71.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 67.86 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 75.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 64.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 85.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 85.71 Percentage of participants |
| Placebo DB | 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 | DB Week 36 | 51.61 Percentage of participants |
| Placebo DB | 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 | DB Week 8 | 80.65 Percentage of participants |
| Placebo DB | 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 | DB Week 12 | 74.19 Percentage of participants |
| Placebo DB | 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 | DB Week 40 | 51.61 Percentage of participants |
| Placebo DB | 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 | DB Week 44 | 51.61 Percentage of participants |
| Placebo DB | 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 | DB Week 48 | 48.39 Percentage of participants |
| Placebo DB | 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 | DB Week 52 | 48.39 Percentage of participants |
| Placebo DB | 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 | DB Week 4 | 93.55 Percentage of participants |
| Placebo DB | 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 | DB Week 16 | 61.29 Percentage of participants |
| Placebo DB | 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 | DB Week 20 | 51.61 Percentage of participants |
| Placebo DB | 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 | DB Week 24 | 54.84 Percentage of participants |
| Placebo DB | 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 | DB Week 28 | 51.61 Percentage of participants |
| Placebo DB | 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 | DB Week 32 | 51.61 Percentage of participants |
Comparison: DB Week 495% CI: [-23.42, 7.75]
Comparison: DB Week 895% CI: [-13.94, 24.08]
Comparison: DB Week 1295% CI: [-21.43, 23.04]
Comparison: DB Week 1695% CI: [-13.82, 34.1]
Comparison: DB Week 2095% CI: [-8.43, 40.92]
Comparison: DB Week 2495% CI: [-15.49, 34.39]
Comparison: DB Week 2895% CI: [-16.13, 34.33]
Comparison: DB Week 3295% CI: [-16.13, 34.33]
Comparison: DB Week 3695% CI: [-16.13, 34.33]
Comparison: DB Week 4095% CI: [-16.13, 34.33]
Comparison: DB Week 4495% CI: [-16.13, 34.33]
Comparison: DB Week 4895% CI: [-12.91, 37.56]
Comparison: DB Week 5295% CI: [-12.91, 37.56]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | 83.51 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | 82.47 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | 90.72 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | 96.39 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | 100 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | 95.83 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | 98.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | 92.31 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | 96.77 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | 90.91 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | 100 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | 100 Percentage of participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 24 | 64.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 40 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 44 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 44 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 48 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 28 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 52 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 24 | 64.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 4 | 28.57 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 32 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 48 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 36 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 16 | 25.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 12 | 71.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 20 | 21.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 40 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 24 | 21.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 52 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 44 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 32 | 14.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 32 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 36 | 28.57 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 48 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 40 | 28.57 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 4 | 82.14 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 44 | 28.57 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 52 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 48 | 28.57 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 16 | 71.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 4 | 57.14 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 4 | 14.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 8 | 82.14 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 8 | 67.86 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 12 | 14.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 36 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 16 | 17.86 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 12 | 64.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 24 | 17.86 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 28 | 14.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 12 | 71.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 32 | 10.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 16 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 36 | 14.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 8 | 82.14 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 20 | 64.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 44 | 21.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 16 | 71.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 48 | 25.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 52 | 25.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 24 | 53.57 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 40 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 28 | 57.14 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 28 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:DB Week 20 | 67.86 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 32 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 8 | 21.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 12 | 25.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 28 | 17.86 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:DB Week 52 | 28.57 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 8 | 10.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 20 | 14.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 20 | 67.86 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:DB Week 36 | 60.71 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:DB Week 40 | 21.43 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:DB Week 4 | 82.14 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 48 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 4 | 93.55 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 8 | 80.65 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 16 | 61.29 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 24 | 54.84 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 32 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 36 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 40 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 44 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 48 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 52 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 4 | 93.55 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 8 | 77.42 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 12 | 70.97 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 16 | 58.06 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 20 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 24 | 54.84 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 28 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 32 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 36 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 40 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 44 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 48 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR50:DB Week 52 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 4 | 70.97 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 8 | 77.42 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 12 | 64.52 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 16 | 54.84 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 20 | 45.16 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 24 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 28 | 41.94 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 32 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 36 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 44 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 48 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 52 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 4 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 8 | 38.71 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 12 | 38.71 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 16 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 20 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 24 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 28 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 32 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 36 | 35.48 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 40 | 32.26 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 44 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 48 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR90:DB Week 52 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 4 | 35.48 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 8 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 12 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 16 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 28 | 22.58 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 32 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 36 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 40 | 29.03 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 44 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 52 | 25.81 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 12 | 70.97 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 20 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR30:DB Week 28 | 51.61 Percentage of participants |
| Placebo DB | 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 | ACR70:DB Week 40 | 48.39 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 20 | 12.90 Percentage of participants |
| Placebo DB | 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 | ACR100:DB Week 24 | 19.35 Percentage of participants |
Comparison: ACR30 at DB Week 495% CI: [-28.02, 5.21]
Comparison: ACR30 at DB Week 895% CI: [-18.37, 21.36]
Comparison: ACR30 at DB Week 1295% CI: [-22.68, 23.6]
Comparison: ACR30 at DB Week 1695% CI: [-13.82, 34.1]
Comparison: ACR30 at DB Week 2095% CI: [-8.43, 40.92]
Comparison: ACR30 at DB Week 2495% CI: [-15.49, 34.39]
Comparison: ACR30 at DB Week 2895% CI: [-16.13, 34.33]
Comparison: ACR30 at DB Week 3295% CI: [-16.13, 34.33]
Comparison: ACR30 at DB Week 3695% CI: [-16.13, 34.33]
Comparison: ACR30 at DB Week 4095% CI: [-16.13, 34.33]
Comparison: ACR30 at DB Week 4495% CI: [-16.13, 34.33]
Comparison: ACR30 at DB Week 4895% CI: [-12.91, 37.56]
Comparison: ACR30 at DB Week 5295% CI: [-12.91, 37.56]
Comparison: ACR50 at DB Week 495% CI: [-28.02, 5.21]
Comparison: ACR50 at DB Week 895% CI: [-15.72, 25.17]
Comparison: ACR50 at DB Week 1295% CI: [-22.68, 23.6]
Comparison: ACR50 at DB Week 1695% CI: [-10.76, 37.48]
Comparison: ACR50 at DB Week 2095% CI: [-5.2, 44.14]
Comparison: ACR50 at DB Week 2495% CI: [-15.49, 34.39]
Comparison: ACR50 at DB Week 2895% CI: [-16.13, 34.33]
Comparison: ACR50 at DB Week 3295% CI: [-16.13, 34.33]
Comparison: ACR50 at DB Week 3695% CI: [-16.13, 34.33]
Comparison: ACR50 at DB Week 4095% CI: [-16.13, 34.33]
Comparison: ACR50 at DB Week 4495% CI: [-12.91, 37.56]
Comparison: ACR50 at DB Week 4895% CI: [-12.91, 37.56]
Comparison: ACR50 at DB Week 5295% CI: [-12.91, 37.56]
Comparison: ACR70 at DB Week 495% CI: [-38.14, 10.49]
Comparison: ACR70 at DB Week 895% CI: [-32.28, 13.15]
Comparison: ACR70 at DB Week 1295% CI: [-24.7, 24.24]
Comparison: ACR70 at DB Week 1695% CI: [-19.31, 31.06]
Comparison: ACR70 at DB Week 2095% CI: [-5.81, 44.06]
Comparison: ACR70 at DB Week 2495% CI: [-23.55, 27.47]
Comparison: ACR70 at DB Week 2895% CI: [-10.05, 40.46]
Comparison: ACR70 at DB Week 3295% CI: [-12.91, 37.56]
Comparison: ACR70 at DB Week 3695% CI: [-16.13, 34.33]
Comparison: ACR70 at DB Week 4095% CI: [-12.91, 37.56]
Comparison: ACR70 at DB Week 4495% CI: [-12.91, 37.56]
Comparison: ACR70 at DB Week 4895% CI: [-12.91, 37.56]
Comparison: ACR70 at DB Week 5295% CI: [-12.91, 37.56]
Comparison: ACR90 at DB Week 495% CI: [-44.09, 4.46]
Comparison: ACR90 at DB Week 895% CI: [-40.19, 5.63]
Comparison: ACR90 at DB Week 2095% CI: [-29.66, 14.45]
Comparison: ACR90 at DB Week 1295% CI: [-37.19, 9.77]
Comparison: ACR90 at DB Week 1695% CI: [-26.67, 18.61]
Comparison: ACR90 at DB Week 3295% CI: [-35.32, 5.83]
Comparison: ACR90 at DB Week 2495% CI: [-26.02, 17.26]
Comparison: ACR90 at DB Week 2895% CI: [-28.89, 12.99]
Comparison: ACR90 at DB Week 3695% CI: [-30.65, 16.83]
Comparison: ACR90 at DB Week 4095% CI: [-27.16, 19.78]
Comparison: ACR90 at DB Week 4495% CI: [-23.6, 22.68]
Comparison: ACR90 at DB Week 4895% CI: [-23.6, 22.68]
Comparison: ACR90 at DB Week 5295% CI: [-23.6, 22.68]
Comparison: ACR100 at DB Week 495% CI: [-42.45, 0.05]
Comparison: ACR100 at DB Week 895% CI: [-37.98, 1.34]
Comparison: ACR100 at DB Week 1295% CI: [-31.65, 8.61]
Comparison: ACR100 at DB Week 1695% CI: [-28.89, 12.99]
Comparison: ACR100 at DB Week 2095% CI: [-16.15, 18.91]
Comparison: ACR100 at DB Week 2495% CI: [-21.36, 18.37]
Comparison: ACR100 at DB Week 2895% CI: [-27.91, 11.32]
Comparison: ACR100 at DB Week 3295% CI: [-34.29, 4.1]
Comparison: ACR100 at DB Week 3695% CI: [-31.65, 8.61]
Comparison: ACR100 at DB Week 4095% CI: [-29.66, 14.45]
Comparison: ACR100 at DB Week 4495% CI: [-26.02, 17.26]
Comparison: ACR100 at DB Week 4895% CI: [-23.04, 21.43]
Comparison: ACR100 at DB Week 5295% CI: [-23.04, 21.43]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | ACR30:Part 2 Week 8 | 87.50 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:Part 2 Week 12 | 90.32 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:Part 2 week 16 | 86.96 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:Part 2 Week 20 | 100 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 2 Week 4 | 86.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 2 Week 8 | 77.50 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 2 Week 12 | 80.65 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 2 Week 8 | 67.50 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 2 Week 12 | 70.97 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 2 Week 16 | 73.91 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 2 Week 20 | 92.31 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 2 Week 24 | 66.67 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 2 Week 4 | 32.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 2 Week 8 | 27.50 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 2 Week 12 | 22.58 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 2 Week 16 | 34.78 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 2 Week 20 | 53.85 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 2 Week 24 | 33.33 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 2 Week 4 | 28.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 2 Week 16 | 26.09 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:Part 2 Week 4 | 90.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:Part 2 Week 24 | 100 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 2 Week 16 | 73.91 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 2 Week 20 | 92.31 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 2 Week 24 | 100 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 2 Week 4 | 68.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 2 Week 8 | 27.50 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 2 Week 12 | 16.13 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 2 Week 20 | 38.46 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 2 Week 24 | 33.33 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | ACR30: Part 1 Week 2 | 42.42 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30: Part 1 Week 4 | 68.04 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30: Part 1 Week 8 | 86.59 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30:Part 1 Week 12 | 90.91 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30: Part 1 Week 16 | 83.33 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 1 Day 7 | 18.18 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 1 Week 2 | 28.28 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 1 Week 4 | 44.33 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 1 Week 8 | 59.04 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 1 Week 12 | 79.55 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR50:Part 1 Week 16 | 75.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 1 Day 7 | 10.10 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 1 Week 2 | 16.16 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 1 Week 4 | 19.59 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 1 Week 12 | 38.64 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 1 Week 16 | 33.33 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 1 Week 2 | 6.06 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 1 Week 4 | 11.34 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 1 Week 8 | 18.29 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 1 Week 12 | 15.91 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 1 Week 16 | 16.67 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 1 Day 7 | 3.03 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 1 Week 4 | 8.25 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 1 Week 8 | 13.41 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 1 Week 12 | 9.09 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 1 Week 16 | 8.33 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR30: Part 1 Day 7 | 26.26 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR70:Part 1 Week 8 | 34.15 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR90:Part 1 Day 7 | 5.05 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | ACR100:Part 1 Week 2 | 5.05 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 3 | 32.63 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | 45.36 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | 49.48 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | 55.67 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | 60.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Baseline | 30.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | 59.09 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | 41.67 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | 76.92 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | 33.33 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | 68.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | 62.50 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | 51.61 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | 54.55 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1 | Part 1 Day 3 | 3.13 Percentage of participants |
| Tofacitinib 5mg BID DB | Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1 | Part 1 Day 7 | 1.03 Percentage of participants |
| Tofacitinib 5mg BID DB | Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1 | Part 1 Day 14 | 4.12 Percentage of participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 7.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 7.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 7.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 10.71 Percentage of Participants |
| Placebo DB | 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 | DB Week 52 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 4 | 25.81 Percentage of Participants |
| Placebo DB | 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 | DB Week 8 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 12 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 16 | 9.68 Percentage of Participants |
| Placebo DB | 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 | DB Week 20 | 9.68 Percentage of Participants |
| Placebo DB | 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 | DB Week 24 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 28 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 32 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 36 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 40 | 25.81 Percentage of Participants |
| Placebo DB | 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 | DB Week 44 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 48 | 19.35 Percentage of Participants |
Comparison: DB Week 495% CI: [-34.29, 4.1]
Comparison: DB Week 895% CI: [-29.08, 4.65]
Comparison: DB Week 1295% CI: [-25.07, 7.1]
Comparison: DB Week 1695% CI: [-12.01, 21.23]
Comparison: DB Week 2095% CI: [-12.01, 21.23]
Comparison: DB Week 2495% CI: [-25.07, 7.1]
Comparison: DB Week 2895% CI: [-30.52, 6.79]
Comparison: DB Week 3295% CI: [-24.08, 13.94]
Comparison: DB Week 3695% CI: [-22.7, 11.87]
Comparison: DB Week 4095% CI: [-31.65, 8.61]
Comparison: DB Week 4495% CI: [-20.16, 16.48]
Comparison: DB Week 4895% CI: [-26.66, 9.38]
Comparison: DB Week 5295% CI: [-24.08, 13.94]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | 0 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | 3.13 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | 3.09 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | 5.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | 4.55 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | 4.17 Percentage of Participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | 16.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | 20.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | 9.68 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | 18.18 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | 38.46 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | 33.33 Percentage of Participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 7.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 17.86 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | 14.29 Percentage of Participants |
| Placebo DB | 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 | DB Week 44 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 32 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 8 | 29.03 Percentage of Participants |
| Placebo DB | 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 | DB Week 52 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 12 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 36 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 16 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 48 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 20 | 12.90 Percentage of Participants |
| Placebo DB | 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 | DB Week 40 | 25.81 Percentage of Participants |
| Placebo DB | 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 | DB Week 24 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 4 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 28 | 22.58 Percentage of Participants |
Comparison: DB Week 495% CI: [-29.08, 4.65]
Comparison: DB Week 895% CI: [-35.32, 5.83]
Comparison: DB Week 1295% CI: [-27.91, 11.32]
Comparison: DB Week 1695% CI: [-17.48, 20.93]
Comparison: DB Week 2095% CI: [-16.15, 18.91]
Comparison: DB Week 2495% CI: [-22.7, 11.87]
Comparison: DB Week 2895% CI: [-30.52, 6.79]
Comparison: DB Week 3295% CI: [-24.08, 13.94]
Comparison: DB Week 3695% CI: [-26.66, 9.38]
Comparison: DB Week 4095% CI: [-31.65, 8.61]
Comparison: DB Week 4495% CI: [-27.91, 11.32]
Comparison: DB Week 4895% CI: [-27.91, 11.32]
Comparison: DB Week 5295% CI: [-24.08, 13.94]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | 0 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | 2.04 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | 1.03 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | 3.70 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | 6.82 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | 4.17 Percentage of Participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | 16.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | 17.50 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | 9.68 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | 17.39 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | 46.15 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | 33.33 Percentage of Participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 7.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 7.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 3.57 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 17.86 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 7.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | 14.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 3.57 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | 17.86 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 10.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | 21.43 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 7.14 Percentage of Participants |
| Placebo DB | 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 | DB Week 52 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 4 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 8 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 12 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 16 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 20 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 24 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 28 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 32 | 19.35 Percentage of Participants |
| Placebo DB | 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 | DB Week 36 | 16.13 Percentage of Participants |
| Placebo DB | 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 | DB Week 40 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 44 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 48 | 22.58 Percentage of Participants |
Comparison: DB Week 495% CI: [-25.07, 7.1]
Comparison: DB Week 895% CI: [-35.25, -2.76]
Comparison: DB Week 1295% CI: [-32.98, 2.1]
Comparison: DB Week 1695% CI: [-27.22, 2.1]
Comparison: DB Week 2095% CI: [-25.07, 7.1]
Comparison: DB Week 2495% CI: [-29.08, 4.65]
Comparison: DB Week 2895% CI: [-26.66, 9.38]
Comparison: DB Week 3295% CI: [-26.66, 9.38]
Comparison: DB Week 3695% CI: [-20.16, 16.48]
Comparison: DB Week 4095% CI: [-25.17, 15.72]
Comparison: DB Week 4495% CI: [-27.91, 11.32]
Comparison: DB Week 4895% CI: [-25.17, 15.72]
Comparison: DB Week 5295% CI: [-18.53, 22.68]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Baseline | 0 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 3 | 0 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | 0 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | 2.02 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | 3.09 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | 4.82 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | 4.55 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | 4.17 Percentage of Participants |
Secondary
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
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 4 | 14.00 Percentage of participants |
| Tofacitinib 5mg BID DB | Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 8 | 10.26 Percentage of participants |
| Tofacitinib 5mg BID DB | Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 12 | 6.45 Percentage of participants |
| Tofacitinib 5mg BID DB | Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 16 | 13.04 Percentage of participants |
| Tofacitinib 5mg BID DB | Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 20 | 15.38 Percentage of participants |
| Tofacitinib 5mg BID DB | Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Week 24 | 33.33 Percentage of participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 35.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 35.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 28.57 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 21.43 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 39.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 35.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 39.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | 46.43 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 32.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | 46.43 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 35.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | 46.43 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 25.00 Percentage of Participants |
| Placebo DB | 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 | DB Week 52 | 29.03 Percentage of Participants |
| Placebo DB | 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 | DB Week 4 | 51.61 Percentage of Participants |
| Placebo DB | 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 | DB Week 8 | 48.39 Percentage of Participants |
| Placebo DB | 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 | DB Week 12 | 32.26 Percentage of Participants |
| Placebo DB | 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 | DB Week 16 | 29.03 Percentage of Participants |
| Placebo DB | 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 | DB Week 20 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 24 | 35.48 Percentage of Participants |
| Placebo DB | 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 | DB Week 28 | 32.26 Percentage of Participants |
| Placebo DB | 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 | DB Week 32 | 22.58 Percentage of Participants |
| Placebo DB | 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 | DB Week 36 | 35.48 Percentage of Participants |
| Placebo DB | 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 | DB Week 44 | 25.81 Percentage of Participants |
| Placebo DB | 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 | DB Week 48 | 25.81 Percentage of Participants |
| Placebo DB | 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 | DB Week 40 | 29.03 Percentage of Participants |
Comparison: DB Week 4495% CI: [-3.43, 44.67]
Comparison: DB Week 4895% CI: [-3.43, 44.67]
Comparison: DB Week 5295% CI: [-7.03, 41.82]
Comparison: DB Week 495% CI: [-53.43, -6.94]
Comparison: DB Week 895% CI: [-47.19, 0.42]
Comparison: DB Week 1295% CI: [-23.99, 23.76]
Comparison: DB Week 1695% CI: [-17.2, 30.56]
Comparison: DB Week 2095% CI: [-9.92, 36.19]
Comparison: DB Week 2495% CI: [-24.24, 24.7]
Comparison: DB Week 2895% CI: [-20.75, 27.66]
Comparison: DB Week 3295% CI: [-16.29, 28.28]
Comparison: DB Week 3695% CI: [-20.92, 28.52]
Comparison: DB Week 4095% CI: [-13.88, 34.39]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | 3.09 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | 5.21 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | 6.19 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | 13.75 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | 13.64 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | 25.00 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | 36.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | 30.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | 32.26 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | 36.36 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | 53.85 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | 33.33 Percentage of participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 32.14 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 28.57 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 39.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 39.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 25.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 39.29 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 35.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | 50.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 35.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | 50.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 35.71 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | 50.00 Percentage of Participants |
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 25.00 Percentage of Participants |
| Placebo DB | 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 | DB Week 52 | 32.26 Percentage of Participants |
| Placebo DB | 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 | DB Week 4 | 51.61 Percentage of Participants |
| Placebo DB | 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 | DB Week 8 | 45.16 Percentage of Participants |
| Placebo DB | 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 | DB Week 12 | 41.94 Percentage of Participants |
| Placebo DB | 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 | DB Week 16 | 35.48 Percentage of Participants |
| Placebo DB | 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 | DB Week 20 | 29.03 Percentage of Participants |
| Placebo DB | 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 | DB Week 24 | 38.71 Percentage of Participants |
| Placebo DB | 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 | DB Week 28 | 38.71 Percentage of Participants |
| Placebo DB | 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 | DB Week 32 | 35.48 Percentage of Participants |
| Placebo DB | 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 | DB Week 36 | 35.48 Percentage of Participants |
| Placebo DB | 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 | DB Week 40 | 32.26 Percentage of Participants |
| Placebo DB | 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 | DB Week 44 | 32.26 Percentage of Participants |
| Placebo DB | 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 | DB Week 48 | 35.48 Percentage of Participants |
Comparison: DB Week 2095% CI: [-13.88, 34.39]
Comparison: DB Week 495% CI: [-50.42, -2.81]
Comparison: DB Week 895% CI: [-43.91, 3.59]
Comparison: DB Week 1295% CI: [-34.31, 14.72]
Comparison: DB Week 1695% CI: [-24.24, 24.7]
Comparison: DB Week 2495% CI: [-27.67, 21.68]
Comparison: DB Week 2895% CI: [-27.67, 21.68]
Comparison: DB Week 3295% CI: [-30.65, 16.83]
Comparison: DB Week 3695% CI: [-20.92, 28.52]
Comparison: DB Week 4095% CI: [-17.43, 31.48]
Comparison: DB Week 4495% CI: [-7.03, 42.52]
Comparison: DB Week 4895% CI: [-10.52, 39.55]
Comparison: DB Week 5295% CI: [-7.03, 42.52]
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 1 Day 7 | 1.02 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 2 | 4.08 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 4 | 7.22 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 8 | 14.81 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 12 | 15.91 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 1 Week 16 | 20.83 Percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 4 | 32.00 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 8 | 27.50 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 12 | 29.03 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 16 | 34.78 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 20 | 53.85 Percentage of participants |
| Tofacitinib 5mg BID DB | 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 | Part 2 Week 24 | 33.33 Percentage of participants |
Secondary
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
Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5mg BID DB | 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 | DB Week 4 | 7.1 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 8 | 14.3 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 12 | 21.4 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 16 | 25.0 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 20 | 32.1 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 24 | 32.1 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 28 | 35.9 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 32 | 35.9 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 40 | 40.5 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 44 | 40.5 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 52 | 40.5 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 36 | 40.5 Percentage probability of occurrence |
| Tofacitinib 5mg BID DB | 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 | DB Week 48 | 40.5 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 28 | 45.4 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 4 | 6.5 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 44 | 55.5 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 8 | 22.6 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 32 | 49.9 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 12 | 32.3 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 36 | 49.9 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 16 | 38.7 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 48 | 55.5 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 20 | 45.4 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 40 | 49.9 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 24 | 45.4 Percentage probability of occurrence |
| Placebo DB | 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 | DB Week 52 | 55.5 Percentage probability of occurrence |
Comparison: DB Week 495% CI: [-12.2, 13.6]
Comparison: DB Week 895% CI: [-27.9, 11.3]
Comparison: DB Week 1295% CI: [-33.2, 11.6]
Comparison: DB Week 1695% CI: [-37.2, 9.8]
Comparison: DB Week 2095% CI: [-37.9, 11.5]
Comparison: DB Week 2495% CI: [-37.9, 11.5]
Comparison: DB Week 2895% CI: [-34.5, 15.6]
Comparison: DB Week 3295% CI: [-39.5, 11.5]
Comparison: DB Week 3695% CI: [-35.5, 16.7]
Comparison: DB Week 4095% CI: [-35.5, 16.7]
Comparison: DB Week 4495% CI: [-41.8, 11.8]
Comparison: DB Week 4895% CI: [-41.8, 11.8]
Comparison: DB Week 5295% CI: [-41.8, 11.8]
Secondary
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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib 5mg BID DB | Time to First Adapted JIA ACR 30 Response: Open-label Phase Part 1 | 27.0 Days |