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A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

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ClinicalTrials.gov Identifier: NCT03000439
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 9, 2016
First Posted Date  ICMJE December 22, 2016
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE May 10, 2018
Estimated Primary Completion Date July 18, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
Time to flare [ Time Frame: Up to 82 weeks after randomization ]
Time to sJIA disease flare in the double-blind phase
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03000439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Occurrence of disease flare in double-blind phase [ Time Frame: Up to 82 weeks after randomization ]
    disease flare frequency by visit in the double-blind phase.
  • Achievement of corticosteroid tapering at the end of the open-label phase [ Time Frame: 12 to 40 weeks ]
    Rate of successful corticosteroid tapering.
  • Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period [ Time Frame: 12 to 40 weeks ]
  • Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phase. [ Time Frame: Up to 82 weeks after randomization ]
  • Fever (Temp >38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phase. [ Time Frame: Day 3, Day 7, Day 14 ]
  • CRP ≤ 10 mg/L at every visit of the open label phase. [ Time Frame: 12 to 40 weeks ]
  • "Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase. [ Time Frame: Up to 82 weeks after randomization. ]
  • Time to first Adapted JIA ACR 30 response in Part 1 of the open label phase. [ Time Frame: 12 to 40 weeks ]
  • Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phase. [ Time Frame: Up to 82 weeks after randomization. ]
  • Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phase. [ Time Frame: Up to 82 weeks after randomization. ]
  • Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafter. [ Time Frame: Up to 82 weeks after randomization. ]
  • Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phase. [ Time Frame: Up to 82 weeks after randomization. ]
  • Occurrence of inactive disease status and minimal disease activity clinical remission at every visit from Day 7 onward (JADAS 27) in the open label and double blind phase. [ Time Frame: Up to 82 weeks after randomization. ]
  • Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phase. [ Time Frame: Up to 82 weeks after randomization. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Official Title  ICMJE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS
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. Once 31 flares are reported the study will be completed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis Juvenile Idiopathic
Intervention  ICMJE
  • Drug: In open-label phase: treatment with tofacitinib
    Treatment with investigational drug
    Other Names:
    • CP-690,550
    • Xeljanz
  • Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
    Treatment with investigational drug or placebo
    Other Names:
    • CP-690,550
    • Xeljanz
Study Arms  ICMJE
  • Experimental: Tofacitinib 5 mg BID
    oral, twice daily, tablet or solution.
    Interventions:
    • Drug: In open-label phase: treatment with tofacitinib
    • Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
  • Placebo Comparator: Placebo
    Intervention: Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
  • Experimental: Tofacitinib 10 mg BID
    oral, twice daily, tablet or solution.
    Interventions:
    • Drug: In open-label phase: treatment with tofacitinib
    • Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 18, 2023
Estimated Primary Completion Date July 18, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • active sJIA disease according to ILAR criteria for at least 6 weeks before screening
  • 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 JIA treatment with tofacitinib;
  • Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with sJIA. Current symptoms or findings of more than minimal pleuritis with sJIA
  • Subjects who have previously failed treatment with more than two biologic DMARDs. Note: all subjects will be allowed to have previously failed one biologic DMARD, and up to forty (40) percent of subjects will be allowed to have previously failed two biologic DMARDs provided that washout periods are respected.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Chile,   China,   Israel,   Mexico,   Russian Federation,   South Africa,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03000439
Other Study ID Numbers  ICMJE A3921165
2017-002018-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP