GSK 201791 contRAst-2
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 conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs.
IRAS ID
269798
Contact name
Peter Taylor
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2019-000867-26
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.
The aim of this study is to determine the efficacy and safety of GSK3196165,in combination with conventional synthetic disease-modifying antirheumatic drugs(csDMARDs), for the treatment of adults with moderately to severely active rheumatoid
arthritis (RA) who have had an inadequate response to csDMARDs or biologic DMARDs
(bDMARDs). Two doses of GSK3196165 (90 mg subcutaneous [SC] weekly and 150mg SC weekly) will be compared with placebo (to Week 12) and with tofacitinib (5 mg
twice daily [BID]), an inhibitor of Janus Kinase (JAK) that is approved for the treatment of adults with moderately to severely active RA who have had an inadequate response to cs/bDMARDs.
Participants will be randomised in a ratio of 6:6:3:1:1:1 to GSK3196165 150 mg SC
weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules 5 mg BID or placebo (3
arms) respectively, all in combination with csDMARD(s). At Week 12, the 3 placebo
arms will switch from placebo to active intervention (either GSK3196165 150 mg SC
weekly, GSK3196165 90 mg SC weekly, or tofacitinib capsules 5 mg BID).
Randomisation will be stratified by previously failed medication (csDMARD only, 1
bDMARD or >1 bDMARD).The total treatment period is 52 weeks, with an 8-week safety follow‑up period after the last SC dose of study intervention for those participants who do not continue into the long term-extension study.
Approximately 3000-3600 participants will be screened to
achieve between 1500 and 1800 randomly assigned to study intervention. Approximately
1500 evaluable participants are expected to be included in the primary analysis, of whom
approximately 1350 are expected to complete the Week 12 visit. The maximum of 1800
participants may be recruited if necessary to ensure sufficient numbers in key Asian
country subgroups.REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0284
Date of REC Opinion
10 Dec 2019
REC opinion
Further Information Favourable Opinion