NCT03381170已完成2 期
An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 9
- 主要终点
- Number of participants with treatment-related events as assessed by CTCAE V4.0
研究概览
简要总结
This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects currently enrolled in TG1101-RMS201 trial
- •Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit
排除标准
- •Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
- •Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
- •Pregnant or nursing mothers
结局指标
主要结局
Number of participants with treatment-related events as assessed by CTCAE V4.0
时间窗: 96 weeks on therapy
to determine the incidence of adverse events and any abnormal laboratory values
次要结局
- Evaluate the % of participants with relapses(up to 96 Weeks)
研究者
研究点 (9)
Loading locations...
相似试验
进行中（未招募）
3 期
An Extension Study of Ublituximab in Participants With Relapsing Multiple SclerosisRelapsing Multiple Sclerosis (RMS)NCT04130997TG Therapeutics, Inc.1,100
已完成
2 期
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple SclerosisMultiple SclerosisNCT02738775TG Therapeutics, Inc.49
终止
2 期
Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 TrialsNon Hodgkin LymphomaChronic Lymphocytic LeukemiaNCT03207256TG Therapeutics, Inc.51
终止
3 期
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT02612311TG Therapeutics, Inc.603
招募中
3 期
An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis2024-516680-91-00Tg Therapeutics Inc.137