GSK 201790 contRAst-1
Research type
Research Study
Full title
A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.
IRAS ID
266684
Contact name
Peter Charles Taylor
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2019-000797-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
121958, IND
Duration of Study in the UK
2 years, 5 months, 18 days
Research summary
Rheumatoid arthritis (RA) is a chronic, systemic inflammatory autoimmune disease, associated with substantial disability and morbidity. RA affects approximately 0.5-1.0% of the worldwide population, primarily women, with a peak incidence of onset between 40 and 60 years of age. A substantial proportion of patients either fail to respond, or have inadequate response, to currently available RA therapies. Therefore, there is still a medical need for more effective treatments for RA with alternative mechanisms of action.
This study involves research of a potential new drug, GSK3196165, also known as otilimab, that is being developed for rheumatoid arthritis (RA) treatment. It will compare the activity of otilimab in potential participants with moderately to severely active RA who have an inadequate response to methotrexate (MTX) versus placebo or tofacitinib. The comparator drug (tofacitinib) is approved in the United Kingdom for moderate-to-severe active rheumatoid arthritis.
Depending on which treatment group participants are in, they will receive otilimab (90 mg subcutaneous [SC] weekly or 150 mg SC weekly), which will be compared with placebo (to Week 12) and with tofacitinib (5 mg twice daily [BID]).
Since the study is double blind the participants will not know whether they are receiving the study drug or comparator. The study comprises of a screening part (up to 6 weeks), a Treatment period (up to 52-week) and a safety follow-up visit (up to 8 week).
Approximately 3000-3400 participants will be screened to achieve between 1500 and 1700 randomly assigned to study intervention. The total treatment period is 52 weeks, with an 8-week safety follow‑up period after the last subcutaneous dose of study intervention for those participants who do not continue into the long term-extension study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0467
Date of REC Opinion
22 Nov 2019
REC opinion
Further Information Favourable Opinion