メトトレキサートとの併用によるアダリムマブ80mg隔週投与の有効性と安全性

基本情報

NCT ID

NCT01270035

ステータス

不明

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

40

治験依頼者名

Keio University

概要

In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 \< 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 \< 2.6) at 30 weeks with this predifined treatment strategy.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)