A3921104 - Tofacitinib for treatment of Juvenile Idiopathic Arthritis

• Research type

  Research Study

• Full title

  Efficacy, safety and tolerability of tofacitinib for treatment of polyarticular course juvenile idiopathic arthritis (JIA) in children and adolescent subjects

• IRAS ID

  234972

• Contact name

  Athimalaipet V. Ramanan

• Contact email

  Athimalaipet.Ramanan@UHbristol.nhs.uk

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2015-001438-46

• Clinicaltrials.gov Identifier

  NCT02592434

• Clinicaltrials.gov Identifier

  PROPEL, A3921104; 117400, US IND

• Duration of Study in the UK

  1 years, 3 months, 9 days

• Research summary

  This is a randomised withdrawal, double blind, Placebo controlled study of patients aged 2 to <18 years of age, with polyarticular course juvenile idiopathic arthritis (JIA).

  The study drug is tofacitinib, already approved for adult use for arthritis in the UK, but not for use in children.

  All patients will received tofacitinib for the first 18 weeks (run-in phase of study). After these 18 weeks, all patients deemed eligible according to their results will enter the double blind phase of the study, where they will be randomised (like a toss of the coin) to receive either tofacitinib or placebo for 26 weeks.

  After the study ends (44 weeks) eligible patients can choose to participate in the open label extension study A3921145.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  17/EM/0468

• Date of REC Opinion

  27 Mar 2018

• REC opinion

  Further Information Favourable Opinion