CompletedPhase 3

Efficacy Study Of Tofacitinib In Pediatric JIA Population

United States225 participantsStarted 2016-06-10

Plain-language summary

Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female aged 2 to \<18 years.
✓. Must meet International League Against Rheumatism (ILAR) JIA diagnostic criteria for one of the following categories with active disease for at least 6 weeks:
✓. Inadequate response or intolerance to at least one Disease Modifying Anti Rheumatic Drug (DMARD), which may include MTX or biologic agents; in the case of ERA and psoriatic arthritis, inadequate response to Non Steroidal Anti Inflammatory Drugs (NSAIDs).
✓. No evidence or history of untreated or inadequately treated active or latent tuberculosis (TB) infection as evidenced by the following:
✓. A negative QuantiFERON ®TB Gold In Tube test performed within the 3 months prior to screening. A negative purified protein derivative (PPD) test can be substituted for the QuantiFERON® TB Gold In Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer medical monitor is informed and agrees on a case by case basis.
✓. Chest radiograph without changes suggestive of active tuberculosis (TB) infection within 3 months prior to screening is recommended and should be performed according to local standards of care or country-specific guidelines.
✓. No history of either untreated or inadequately treated latent or active TB infection.
✓. Fertile males and females who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be willing and able to use a highly effective method of contraception as outlined in this protocol during the study and for at least 28 days after the last dose of study medication.

Exclusion criteria

✕. Previous JIA treatment with tofacitinib.
✕. Systemic JIA (sJIA) with active systemic features (including subjects with characteristic sJIA fever and rash or serositis within 6 months of enrollment).
✕. Persistent oligoarthritis.
✕. Undifferentiated JIA.
✕. Infections:
✕. Chronic infections;
✕. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug;
✕. Any treated infections within 2 weeks of Baseline visit;

What they're measuring

Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44

Timeframe: Week 44

Trial details

NCT IDNCT02592434

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-16

Results submitted2020-02-06

View on ClinicalTrials.gov More Juvenile Idiopathic Arthritis trials