Clinical Trial

Testing Experimental Treatment of Rheumatoid Arthritis

Study Description

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

This is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional synthetic disease modifying antirheumatic drugs (csDMARD[s]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARD[s]) and/or Janus Kinase (JAK) inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 mg subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). Following the treatment phase, there will be a safety follow-up visit at Week 34 for those participants who do not continue into the long term-extension study.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Biological - GSK3196165

GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered subcutaneously (SC).

Biological - Sarilumab

Sarilumab solution in pre-filled syringe (PFS) to be administered subcutaneously (SC).

Drug - Placebo to GSK3196165/ Sarilumab

Placebo sterile 0.9% w/v sodium chloride solution in vial/pre-filled syringe (PFS) to be administered subcutaneously (SC).

Drug - csDMARDs

Stable dose of csDMARD(s) as standard of care (SoC).

Additional Information

Official Study Title

A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors

Clinical Trial ID

NCT04134728

ParticipAid ID

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