Efficacy Study Of Tofacitinib In Pediatric JIA Population
NCT02592434
ABOUT THIS STUDY

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1. Male or female aged 2 to 17 years.
2. Must have diagnosis of one of the following JIA subcategories: ◦Extended oligoarthritis; ◦Polyarthritis (RF+); ◦Polyarthritis (RF-); ◦Systemic JIA with active arthritis but without active systemic features in the prior 6 months and at the time of enrollment; ◦Psoriatic arthritis; ◦Enthesitis related arthritis.
3. Depending on JIA diagnosis, participants must have at minimum 3 to 5 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4. Inadequate response or intolerance to at least one Disease Modifying Anti Rheumatic Drug (DMARD), which may include Methotrexate or biologic agents.
Key
1. Active uveitis within 3 months of enrollment.
2. History of any other rheumatologic disease, other than Sjogren's syndrome.
3. Previously failed more than 3 biologic therapies (with different mechanisms of action) for JIA.
4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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Descriptive Information | |||||||
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Brief Title ICMJE | Efficacy Study Of Tofacitinib In Pediatric JIA Population | ||||||
Official Title ICMJE | EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS | ||||||
Brief Summary | Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients. | ||||||
Detailed Description | This is a randomized withdrawal, double blind, placebo controlled study of pediatric subjects (2 to <18 years of age) with JIA. The primary objective is to compare the efficacy of tofacitinib versus placebo for the treatment of signs and symptoms of JIA at Week 26 of the double blind phase as measured by the percentage of subjects with disease flare (according to PRCSG/PRINTO Disease Flare criteria) after Week 18 of the open label run in phase.All eligible subjects enrolled in the study will initially receive open label tofacitinib for 18 weeks (run in phase). At the end of the 18 week run in phase, only subjects who achieve at least a JIA ACR 30 response will be randomized to the 26 week double blind, placebo controlled phase. Subjects who do not achieve a JIA ACR 30 response at this time point will be discontinued from the study. In addition, subjects who experience a single episode of disease flare at any time during the study (including the open label run in and double blind phase) will also be discontinued from the study. All subjects participating in this study, including those discontinued from the study, will have the option, if eligible (based on inclusion and exclusion criteria), of enrolling in the tofacitinib JIA long term extension study (A3921145). Subjects who are eligible for the 26 week double blind phase will be randomized (1:1 ratio) to either active tofacitinib or placebo. For subjects with polyarticular course JIA (ie, extended oligoarthritis, polyarthritis RF+, polyarthritis RF , systemic JIA with active arthritis but without active systemic features), randomization will be stratified by JIA category and baseline CRP (normal, above normal). For subjects with psoriatic and enthesitis related arthritis, randomization will be stratified by JIA category. Approximately 210 subjects will be enrolled in the open label run in phase. Among subjects with polyarticular course JIA, stratification will target at least 50% with a baseline CRP above the upper limit of normal. The first cohort (ie, polyarticular course JIA) will have at least 170 subjects enrolled in the run in phase with the minimum number of JIA categories as follows: 24 with extended oligoarthritis, 20 with polyarthritis RF+, 62 with polyarthritis RF-, and no minimum for subjects with systemic JIA with active arthritis but without active systemic features. Additional cohorts (ie, psoriatic and enthesitis related arthritis) will include a minimum of 20 subjects with psoriatic arthritis, and 20 subjects with enthesitis related arthritis. The overall target minimum number of subjects to be enrolled in the study by age is as follows: 20 subjects 2 to <6 years, 20 subjects 6 to <12 years, and 20 subjects 12 to <18 years. The duration of subject participation among those who complete the study (without discontinuation) is expected to be approximately 44 weeks. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Juvenile Idiopathic Arthritis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 225 | ||||||
Original Estimated Enrollment ICMJE | 210 | ||||||
Actual Study Completion Date ICMJE | May 16, 2019 | ||||||
Actual Primary Completion Date | May 16, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
6 Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 7. Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study. Exclusion Criteria Subjects with any of the following characteristics/conditions will not be included in the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 2 Years to 17 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Canada, Israel, Mexico, Poland, Russian Federation, Spain, Turkey, Ukraine, United Kingdom, United States | ||||||
Removed Location Countries | Chile, Germany, South Africa, Switzerland | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02592434 | ||||||
Other Study ID Numbers ICMJE | A3921104 2015-001438-46 ( EudraCT Number ) PROPEL STUDY ( Other Identifier: Alias Study Number ) PROPEL ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | March 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |