日本人関節リウマチ患者を対象としたE6011の研究

基本情報

NCT ID

NCT02196558

ステータス

完了

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

53

治験依頼者名

Eisai Inc.

概要

This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011 in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400 mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011. Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks after the initial administration.

対象疾患

介入

依頼者（Sponsor）