Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis
NCT01500551
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis | ||||||
Official Title ICMJE | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | ||||||
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. 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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Juvenile Idiopathic Arthritis | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Tofacitinib
All patients will be in tofacitinib treatment group. Interventions:
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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 | 340 | ||||||
Original Estimated Enrollment ICMJE | 290 | ||||||
Estimated Study Completion Date ICMJE | November 26, 2024 | ||||||
Estimated Primary Completion Date | November 26, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 2 Years to 18 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Canada, China, Germany, Israel, Mexico, Poland, Russian Federation, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States | ||||||
Removed Location Countries | Chile, Hungary, Switzerland | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01500551 | ||||||
Other Study ID Numbers ICMJE | A3921145 2011-004915-22 ( EudraCT Number ) JIA ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |