抗TNF-α療法に反応しない活動性関節リウマチ患者におけるオクレリズマブとプラセボの比較試験（SCRIPT）

基本情報

NCT ID

NCT00476996

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

836

治験依頼者名

Genentech, Inc.

概要

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.

対象疾患

介入

依頼者（Sponsor）

実施施設 (11)