Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
- Registration Number
- NCT01500551
- Lead Sponsor
- Pfizer
- Brief Summary
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
- Detailed Description
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.
For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first.
The total duration of an individual subject's participation may vary depending upon when they enter the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
- 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.
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persistent oligoarthritis, and undifferentiated JIA.
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Infections:
- Chronic infections.
- Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
- Any treated infections within 2 weeks of baseline visit.
- A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tofacitinib Tofacitinib All patients will be in tofacitinib treatment group.
- Primary Outcome Measures
Name Time Method Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collected to assess growth and physical development. up to 8 years
- Secondary Outcome Measures
Name Time Method In subjects with sJIA: "Absence of Fever", defined as absence of fever due to sJIA in the week preceding the assessment at each visit. up to 8 years Eligibility of tapering defined per protocol for corticosteroids up to 8 years Physician global evaluation of disease activity at each visit. up to 8 years Number of joints with active arthritis at each visit. up to 8 years Index of inflammation (C-reactive protein [CRP] and Erythrocyte Sedimentation Rate [ESR]) at each visit. up to 8 years Parent's Assessment of Physical Function (Childhood Health Assessment Questionnaire [CHAQ]Disability Index)at each visit. up to 8 years Parent's Assessment of Child's Arthritis Pain (Childhood Health Assessment Questionnaire [CHAQ] Discomfort Index, Visual Analog Scale [VAS])at each visit. up to 8 years Parent's Global Assessment of Overall Wellbeing (Childhood Health Assessment Questionnaire [CHAQ] subsection, Visual Analog Scale [VAS])at each visit. up to 8 years JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit. up to 8 years JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. up to 8 years Eligibility of tapering defined per protocol for methotrexate up to 8 years Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27- CRP and JADAS 27-ESR, and occurrence of JADAS minimum disease activity and inactive disease at each visit. up to 8 years In subjects with Enthesitis Related Arthritis (ERA): Change from baseline in the Tender Entheseal Assessment, Modified Schober's Test, Overall Back Pain and Nocturnal Back Pain responses at various visits. up to 8 years In subjects with psoriatic arthritis (PsA): Change from baseline in body surface area (BSA) affected by psoriasis and Physician's Global Assessment (PGA) of psoriasis) at various visits. up to 8 years Eligibility of tapering defined per protocol for leflunomide Up to 8 years Eligibility of tapering defined per protocol for tofacitinib Up to 8 years Number of joints with limitation of motion at each visit. up to 8 years
Trial Locations
- Locations (103)
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Loma Linda University Children'S Hospital
🇺🇸Loma Linda, California, United States
Loma Linda University Clinical Trials Center
🇺🇸Loma Linda, California, United States
Loma Linda University Eye Institute
🇺🇸Loma Linda, California, United States
Loma Linda University General Pediatric Clinic - Meridian
🇺🇸Loma Linda, California, United States
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
🇺🇸San Bernardino, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Rady Children's Hospital Center for Pediatric Clinical Research
🇺🇸San Diego, California, United States
Rady Children's Hospital Rheumatology Clinic
🇺🇸San Diego, California, United States
Rady Children's Hospital San Diego- Education and Office Building
🇺🇸San Diego, California, United States
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