A3921192 SOAR - A Study of a Once-A-day investigational drug for RA
Research type
Research Study
Full title
A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION
IRAS ID
212375
Contact name
Theresa BARNES
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2016-001825-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117389, IND Number
Duration of Study in the UK
1 years, 11 months, 5 days
Research summary
Tofacitinib Immediate Release (IR) 5 mg twice daily (BID) has been shown in previous trials to reduce the signs and symptoms of the inflammatory condition rheumatoid arthritis (RA), improving physical function, fatigue, pain and quality of life, both when taken alone or in combination with methotrexate (MTX). Tofacitinib is believed to interfere with the activity of an enzyme, Janus kinase (JAK), which is part of the immune and inflammatory responses in the body. By reducing the immune response, tofacitinib reduces the symptoms of RA. However, it remains unknown whether tofacitinib will remain effective after withdrawal of MTX in RA patients who achieve low disease activity following treatment with MTX plus tofacitinib. \nTherefore, the current Phase 3b/4 study will investigate if continued MTX treatment is necessary in patients who have responded to the combined therapy of tofacitinib and MTX. To enable once daily dosing, Pfizer has developed a modified release (MR) tablet formulation of tofacitinib at a dose strength of 11 mg. As MR 11 mg once a day has been shown to move through the body in an equivalent way to tofacitinib IR 5 mg BID, it is expected to be as effective and safe. For the first 24 weeks, tofacitinib MR will be added to patients’ stable dose of methotrexate. Then participants will be randomised to receive either tofacitinib MR plus methotrexate or tofacitinib MR plus placebo, half (50%) of participants in each treatment group. \n580 people from 22 countries are expected to be enrolled in this study. Participants will be in the study for 13 months, will need to visit the study site around 7 times during the study and take a follow up phone call. Tests include blood and urine testing, physical examinations, ECG, completion of RA assessments and lifestyle questionnaires, and possibly a chest x-ray.\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0019
Date of REC Opinion
3 Apr 2017
REC opinion
Further Information Favourable Opinion