Last updated on July 2019

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


Brief description of study

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

Detailed Study Description

This is a Phase 2/3, long term, openlabel, followup 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.

Clinical Study Identifier: NCT01500551

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Phoenix Children's Hospital

Phoenix, AZ United States
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Arkansas Children's Hospital

Little Rock, AR United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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IDS Pharmacy

Washington, WA United States
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Augusta University

Augusta, GA United States
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Pharmacy Department

Bronx, NY United States
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CUMC Research Pharmacy

New York, NY United States
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Carolinas HealthCare System

Charlotte, NC United States
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Primary Children's Hospital Pharmacy

Salt Lake City, UT United States
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Primary Children's Hospital

Salt Lake City, UT United States
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Seattle Children's Hospital

Seattle, WA United States
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Centro Medico Privado de Reumatologia

San Miguel de Tucuman, Argentina
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Bioreuma

Concepcion, Chile
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Klinikum Bad Bramstedt

Bad Bramstedt, Germany
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FSBEI HE "Kazan SMU" MoH RF

Kazan, Russian Federation
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FSAI "NMRCCH" of MOH Russia

Moscow, Russian Federation
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Emmed Research

Pretoria, South Africa
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Recruitment Status: Open


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