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

Last updated on April 14, 2018

FOR MORE INFORMATION
Study Location
Rady Children's Hospital Center for Pediatric Clinical Research
San Diego, California, 92123 United States
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.

NCT03000439
Pfizer
Not yet recruiting
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

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A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Efficacy, Safety, Tolerability And Pharmacokinetics Of Tofacitinib For Treatment Of Systemic Juvenile Idiopathic Arthritis (Sjia) With Active Systemic Features In Children And Adolescent Subjects
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis Juvenile Idiopathic
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
April 6, 2023
April 6, 2023   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada,   United States
 
 
NCT03000439
A3921165
2017-002018-29 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

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