At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Rheumatoid arthritis for ≥6 months, diagnosed at age ≥16 years
- ✓Active disease: ≥6 tender joints (TJC) AND ≥6 swollen joints (SJC)
- ✓Currently taking 1-2 csDMARDs (methotrexate, hydroxychloroquine, chloroquine, sulfasalazine, leflunomide, bucillamine, iguratimod, or tacrolimus) for ≥12 weeks
- ✕Active and/or recurrent infections (excluding recurrent fungal infections of nail bed), or required management of acute or chronic infections
- ✕Prior treatment with GM-CSF antagonist or receptor antagonist
- ✕Known HIV infection or current acute or chronic hepatitis B and/or hepatitis C
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GSK3196165 (Otilimab), Sarilumab, and 2 other interventions for Arthritis, Rheumatoid. Completed, enrolled 550 participants across 131 sites in 15 countries.
Detailed Summary
This study (contRAst 3 \[202018: NCT04134728\]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD\[s\]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD\[s\]) and/or 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 milligrams (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). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study (contRAst X \[209564: NCT04333147\]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).
Study Details
Timeline
Interventions
GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered SC.
Sarilumab solution in PFS to be administered SC.
Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.
Stable dose of csDMARD(s) as SoC.