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A Safety,Tolerability and Efficacy Study Of Tofacitinib In Pediatric Patients With Systemic Juvenile Idiopathic Arthritis

Last updated on October 16, 2019

FOR MORE INFORMATION
Study Location
Alberta Children's Hospital/University of Calgary
Calgary, Alberta, T3B 6A8 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis Juvenile Idiopathic
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Liquid
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
Duration
The time commitment for participation in the study.
Follow up: Up to 4 weeks
Screening: Up to 30 days
Treatment: Range 16 weeks
Site Visits
Follow up: Estimated 1 visits
Screening: At least 1 visits
Treatment: Range 8 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Planned
Trial Procedures
Blood test
Physical examination
Urine test
Vital signs and measurements
Questionnaire
Keeping a diary
X-rays
NCT03000439
Pfizer
Recruiting
A Safety,Tolerability and Efficacy Study Of Tofacitinib In Pediatric Patients With Systemic Juvenile Idiopathic Arthritis

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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 SummaryA 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 DescriptionNot 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
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 August 7, 2023
Estimated Primary Completion DateAugust 6, 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 Center1-800-718-1021[email protected]
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 CommitteeYes
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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