NCT03970837

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,764 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	GSK3196165 (Otilimab)	GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.
DRUG	Tofacitinib	Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.
DRUG	Placebo	Placebo matching GSK3196165 and Tofacitinib was administered.

Timeline

• Start date: 2019-06-05
• Primary completion: 2021-10-29
• Completion: 2023-01-18
• First posted: 2019-06-03
• Last updated: 2023-11-30
• Results posted: 2023-11-30

Locations

269 sites across 18 countries: United States, Argentina, Australia, Bulgaria, China, Colombia, Estonia, France, Germany, Hungary, Japan, Mexico, Poland, Russia, South Korea, Spain, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study