A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Summary

Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX. Secondary Objective: -To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

Timeline

Start

2014-11

Primary completion

2016-10

Completion

2016-10

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Sarilumab 150 mg; p <0.0001; Odds Ratio (OR) 12.185 (95% CI 5.583 to 26.594); NCT02293902 ↗

registry analysis (superiority test); Placebo vs Sarilumab 200 mg; p <0.0001; Odds Ratio (OR) 7.227 (95% CI 3.446 to 15.158); NCT02293902 ↗

Publications

• Tanaka Y, Takahashi T, Van Hoogstraten H, Praestgaard A, Kato N, Kameda H. Haemoglobin changes and disease activity in Japanese patients with rheumatoid arthritis treated with sarilumab. Clin Exp Rheumatol. 2023 May;41(5):1129-1139. doi: 10.55563/clinexprheumatol/jq9u8f. Epub 2022 Oct 28.
• Tanaka Y, Wada K, Takahashi Y, Hagino O, van Hoogstraten H, Graham NMH, Kameda H. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan. Arthritis Res Ther. 2019 Mar 20;21(1):79. doi: 10.1186/s13075-019-1856-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sarilumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Sarilumab	Monoclonal antibody	200 mg	Subcutaneous
Background	Methotrexate	Small molecule	—	—
Background	folic acid	Other / unclassified	—	—

Indications