Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Status:
Recruiting
Trial end date:
2023-09-21
Target enrollment:
Participant gender:
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.