A3921145 - Long Term study of Tofacitinib for Treatment of JIA
Research type
Research Study
Full title
A Long-Term, Open-Label Follow-Up Study of Tofacitinib for Treatment of Juvenile Idiopathic Arthritis (JIA)
IRAS ID
235158
Contact name
Kate Armon
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2011-004915-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
This is a Phase 2/3, long term, open-label, follow-up study, as an extension of treatment for the tofacitinib study participants who completed a qualifying /index study in the JIA program. (A3921103, A3921104 & A3921165 studies). Tofacitinib is approved in the UK for adult use in patients with Rheumatoid Arthritis.
This study is being done to examine the long-term safety and efficacy of an investigational drug (tofacitinib) in children and adolescents with Juvenile Idiopathic Arthritis (JIA).
Approximately 340 participants are projected to enroll and this study is planned to run until the first global marketing approval of tofacitinib for the treatment of JIA. This study could run for up to a 10 years. The total duration of an individual participant's participation may vary depending upon when they entered the trial.
The participant will receive tofacitinib orally twice daily. The dosage (amount) of tofacitinib will be based on the participant's weight and on the study the participant, participated in to qualify for this study.
Depending on when the participant enters the study, he/she will need to visit the research site up to 43 times (4 times a year) during the course of the study, in addition to potential phone contact in between visits.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0015
Date of REC Opinion
27 Mar 2018
REC opinion
Further Information Favourable Opinion