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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)