EUCTR2019-000069-19-SE进行中（未招募）1 期
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For Main Study and MRI Sub-Study:
- •1. Patients with MS randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received = 1 course of IMP (Cladribine Tablets or placebo).
- •Patients with their FCDE randomised in ORACLE MS clinical trial who have received
- •= 1 course of IMP (Cladribine Tablets or placebo).
- •2. Patients can give signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 920
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Main study:
- •Any condition, including any uncontrolled disease state other than MS, that in the Investigator’s
- •opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that
- •could interfere with the study objectives, conduct, or evaluation.
- •MRI-Substudy:
- •a. Female study participants who are pregnant
- •b. Patient is taking Cladribine Tablets as part of another study at the time of the start of
- •this study (i.e. patients participating in a clinical trial or observational study but do not
- •receive Cladribine Tablets as part of these studies are allowed to participate in the substudy).
研究者
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