NCT04333147

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,916 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X \[209564: NCT04333147\]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) \[csDMARD(s)\] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	Otilimab (GSK3196165)	GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.
DRUG	csDMARD(s)	Stable dose of csDMARD(s) as standard of care (SoC).

Timeline

• Start date: 2020-05-12
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2020-04-03
• Last updated: 2024-02-07
• Results posted: 2024-02-07

Locations

375 sites across 27 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Malaysia, Mexico, Poland, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study