Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

Summary

This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group, placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into the study, following a screening period of up to four weeks. The total treatment period is up to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in combination with MTX (at a weekly dose between 15-25 milligram \[mg\]), previously received for at least 12 weeks, with a stable and tolerated dose and route of administration for \>=4 weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that do not achieve adequate disease improvement.

Timeline

Start

2015-07-23

Primary completion

2017-12-22

Completion

2017-12-29

Publications

• Background Buckley CD, Simon-Campos JA, Zhdan V, Becker B, Davy K, Fisheleva E, Gupta A, Hawkes C, Inman D, Layton M, Mitchell N, Patel J, Saurigny D, Williamson R, Tak PP. Efficacy, patient-reported outcomes, and safety of the anti-granulocyte macrophage colony-stimulating factor antibody otilimab (GSK3196165) in patients with rheumatoid arthritis: a randomised, phase 2b, dose-ranging study. Lancet Rheumatol. 2020 Nov;2(11):e677-e688. doi: 10.1016/S2665-9913(20)30229-0. Epub 2020 Oct 7.

Drugs

Indications