NCT00144651已完成2 期
An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- ACR 20% responder rate compared to the pre-treatment in the preceding study
研究概览
简要总结
This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
- •Patients confirmed to have shown the safety in the preceding study.
排除标准
- •Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
- •Patients who received any of the following treatments between the start of preceding study and the registration of this study.
- •Plasma exchange therapy
- •Surgical treatment (e.g., operation)
研究组 & 干预措施
1
Experimental
干预措施: MRA(Tocilizumab) (Drug)
结局指标
主要结局
ACR 20% responder rate compared to the pre-treatment in the preceding study
时间窗: throughout study
Frequency and severity of adverse events and adverse drug reactions
时间窗: week0,week4,week8,week12,and LOBS
次要结局
- Time course of DAS28,compared to the pre-treatment in the preceding study(week 0,week 4,week 8,week 12, LOBS)
- Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study(week 0,week 4,week 8,week 12, LOBS)
- ACR N AUC compared to the pre-treatment in the preceding study(week 0,week 4,week 8,week 12, LOBS)
- Time course of the ACR core set variables compared to the pre-treatment in the preceding study(week 0,week 4,week 8,week 12, LOBS)
研究者
相似试验
招募中
2 期
A Study of AT-02 in Subjects With Systemic Amyloidosis.Systemic AmyloidosisNCT05951049Attralus, Inc.120
终止
2 期
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) StudyUrticariaNCT03693625Genentech, Inc.31
已完成
3 期
Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)Systemic Juvenile Idiopathic ArthritisNCT00144612Chugai Pharmaceutical60
进行中（未招募）
2 期
Phase 2 Open-label Extension Study of AOC 1020 in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)FSHDFSHD1FSHD2FMDFMD2Fascioscapulohumeral Muscular DystrophyFascioscapulohumeral Muscular Dystrophy Type 1Fascioscapulohumeral Muscular Dystrophy Type 2Dystrophies, Facioscapulohumeral MuscularDystrophy, Facioscapulohumeral MuscularFacioscapulohumeral Muscular Dystrophy 1Facioscapulohumeral Muscular Dystrophy 2Facio-Scapulo-Humeral DystrophyAtrophy, FacioscapulohumeralAtrophies, FacioscapulohumeralFacioscapulohumeral AtrophyMuscular DystrophiesMuscular Dystrophy, FacioscapulohumeralFSH Muscular DystrophyLandouzy Dejerine DystrophyLandouzy-Dejerine Muscular DystrophyDystrophies, Landouzy-DejerineDystrophy, Landouzy-DejerineLandouzy-Dejerine SyndromeMuscular Dystrophy, Landouzy DejerineFSHProgressive Muscular DystrophyNCT06547216Avidity Biosciences, Inc.84
已完成
2 期
An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid ArthritisRheumatoid ArthritisNCT02049138AbbVie493