Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis

  • Interventional
  • Recruiting
  • NCT01500551
Eligibility Details Visit Clinicaltrials.gov

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

This is a Phase 2/3, long term, open‑label, follow‑up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study.

     Approximately 340 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.

     This study (A3921145) is planned to run until the first global marketing approval of tofacitinib for the treatment of JIA. The total duration of an individual subject's participation may vary depending upon when they enter the trial.

Gender
All

Age Group
2 Years to 18 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.

         - The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.

         - Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.

         - Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.

        Exclusion Criteria:

         - Systemic JIA (sJIA) with active systemic features other than active joints and elevated acute phase reactants, persistent oligoarthritis, and undifferentiated JIA.

         - Infections:

             1. Chronic infections.

             2. 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.

             3. Any treated infections within 2 weeks of baseline visit.

             4. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.

             5. History of infected joint prosthesis with prosthesis still in situ.

         - History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
  • Pediatric Arthritis

At a Glance

National Government IDNCT01500551

IRB#IRB16-0732

Lead SponsorPfizer

Lead PhysicianLinda Wagner-Weiner

Collaborator(s)N/A

EligibilityAll
2 Years to 18 Years
Recruiting