Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.

Summary

The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.

Timeline

Start

2018-08-30

Primary completion

2019-11-30

Completion

2020-05-28

Outcome

Missed primary endpoint

paper The primary endpoint was not achieved. PMID 37217273 ↗

Publications

• Takeuchi T, Tanaka S, Murata M, Tanaka Y. Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial. Ann Rheum Dis. 2023 Aug;82(8):1025-1034. doi: 10.1136/ard-2022-223759. Epub 2023 May 22.

Drugs

Indications