← 治験一覧に戻る
活動性関節リウマチで抗TNFα製剤への反応が不十分な患者におけるセクキヌマブ(AIN457)の24週時点での有効性、安全性、忍容性、および最長2年間の長期有効性
基本情報
- NCT ID
- NCT01377012
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 637
- 治験依頼者名
- Novartis
概要
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
対象疾患
Rheumatoid Arthritis
介入
Secukinumab (AIN457)(BIOLOGICAL)
Placebo(BIOLOGICAL)
依頼者(Sponsor)
ノバルティスファーマ株式会社(INDUSTRY)