A3921165 - Tofacitinib for treatment of sJIA in Children
Research type
Research Study
Full title
EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS
IRAS ID
254167
Contact name
Carlo Bello
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2017-002018-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
US IND Number, 117400
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The study drug is tofacitinib, already approved for adult use for arthritis in the UK, but not for use in children.
This is a study to compare the effectiveness of toficitinib, over placebo and how it is tolerated in children and adolescents aged 2 - 17 with Systemic Juvenile Idiopathic Arthritis (sJIA).
There are 2 phases in this study. The Open label phase and the Double blind withdrawal phase.
The open label phase has 2 parts. (12-40 weeks)
In Part 1 all participants must achieve and maintain a minimum level of response for at least 4 weeks on oral tofacitinib. In part 2 all participants treated with background oral Corticosteroids (CS) or equivalent must taper their CS dose while maintaining a defined clinical response. The minimum duration, of the participant's treatment in the open label phases with stable dose of tofacitinib is 12 weeks to qualify to enter the randomised double blind phase of this study.The double blind withdrawal phase will randomise participants to receive either Tofacitinib or Placebo (sugar pill). Participants who are able to maintain an adapted JIA ACR (American College of Rheumatology) 30 Response, for at least 4 weeks in the open label phase are eligible for this phase. The double blind phase will continue until disease flare is reported in a total of 31 participants. This phase's duration will be approximately 82 weeks.
This study will be conducted over approximately 5 years.
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0603
Date of REC Opinion
15 Nov 2021
REC opinion
Further Information Favourable Opinion