Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan

Summary

This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.

Timeline

Start

2018-04-18

Primary completion

2021-05-11

Completion

2021-05-11

Outcome

Met primary endpoint

paper an adjusted risk difference of 6·4% (90% CI -7·0 to 19·8), which met the non-inferiority margin of -15% PMID 38251524 ↗

paper The MIRACLE study showed that the efficacy of adalimumab combined with reduced methotrexate dose was not inferior to that with the maximum tolerated methotrexate dose PMID 38251524 ↗

Publications

• Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, Hirata S, Okano Y, Sato S, Yasuoka H, Kuwana M, Ishii T, Kameda H, Kojima T, Nishi Y, Mori M, Miyagishi H, Toshima G, Sato Y, Tsai WC, Takeuchi T, Kaneko Y; MIRACLE Study Group. Association of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial. Ann Rheum Dis. 2025 Jan;84(1):41-48. doi: 10.1136/ard-2024-226350. Epub 2025 Jan 2.
• Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, Hirata S, Okano Y, Sato S, Yasuoka H, Kuwana M, Ishii T, Kameda H, Kojima T, Taninaga T, Mori M, Miyagishi H, Sato Y, Tsai WC, Takeuchi T, Kaneko Y; MIRACLE study collaborators. Reduced versus maximum tolerated methotrexate dose concomitant with adalimumab in patients with rheumatoid arthritis (MIRACLE): a randomised, open-label, non-inferiority trial. Lancet Rheumatol. 2023 Apr;5(4):e215-e224. doi: 10.1016/S2665-9913(23)00070-X.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Methotrexate	Small molecule	6 mg	Oral
Subject	Methotrexate	Small molecule	8 mg	Oral

Indications