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Clinical Trials/NCT03000439
NCT03000439CompletedPhase 3

EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS

Pfizer52 sites in 19 countries100 target enrollmentStarted: May 10, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Pfizer
Enrollment
100
Locations
52
Primary Endpoint
Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts 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.

Arms & Interventions

Tofacitinib 5 mg BID

Experimental

oral, twice daily, tablet or solution.

Intervention: In open-label phase: treatment with tofacitinib (Drug)

Tofacitinib 5 mg BID

Experimental

oral, twice daily, tablet or solution.

Intervention: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio (Drug)

Placebo

Placebo Comparator

Intervention: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio (Drug)

Outcomes

Primary Outcomes

Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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 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 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 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 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)
  • Time to First Adapted JIA ACR 30 Response: Open-label Phase Part 1(From Day 1 up to 16 weeks)
  • Change From Open Label Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) Erythrocyte Sedimentation Rate (ESR) at Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16)
  • Change From Open-Label Baseline in JADAS-27 CRP at Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16)
  • Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24)
  • Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24)
  • Change From Double-Blind Baseline in JADAS-27 ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(DB Baseline (at randomization on Day 1 in DB phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Double-Blind Baseline in JADAS-27 CRP at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(DB Baseline (at randomization on Day 1 in DB phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16)
  • Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24)
  • Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16)
  • Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24)
  • Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16)
  • Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24)
  • Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16)
  • Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24)
  • Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Days 3,7, Part 1 Weeks 2, 4, 8, 12, 16)
  • Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24)
  • Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16)
  • Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2(Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24)
  • Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(OL baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(DB Baseline (values at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(OL label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(DB label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase(OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Change From 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (52)

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