NCT03980483

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,537 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study \[contRAst 1 (201790: NCT03980483)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. 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 MTX. 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) to be administered SC.
DRUG	Tofacitinib 5 mg	Tofacitinib cap (over encapsulated 5mg tablet) to be administered orally.
DRUG	Placebo	Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/pre-filled syringe (PFS) to be administered SC.
DRUG	Placebo	Placebo cap (containing lactose) to be administered orally.

Timeline

• Start date: 2019-05-16
• Primary completion: 2021-09-15
• Completion: 2022-08-16
• First posted: 2019-06-10
• Last updated: 2024-03-27
• Results posted: 2023-10-25

Locations

76 sites across 10 countries: China, Hungary, India, Italy, Malaysia, Poland, Russia, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study