A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).
详细描述
tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG.
After receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG.
Study tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has completed Study tMG.
- •Participant has given written informed consent.
- •MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study
排除标准
- •Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the past 4 weeks;
- •Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;
- •planned thymectomy during RCP;
- •Received IVIG or plasma exchange in the past 4 weeks;
- •Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.
研究组 & 干预措施
tocilizumab
Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.
干预措施: Tocilizumab Injection (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)
次要结局
- Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks(16 weeks)
- Change in Quantitative Myasthenia Gravis (QMG) scores.(16 weeks)
- Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks(16 weeks)
- Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score(16 weeks)
- Change in Myasthenia Gravis Composite (MGC) score(16 weeks)
- Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.(16 weeks)
研究者
changting
Associate Professor
Tang-Du Hospital