Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis
- Conditions
- Multiple SclerosisMS, Multiple Sclerosis
- Registration Number
- LBCTR2020030215
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
1. Patients with MS randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received = 1 course of IMP (Cladribine Tablets or placebo).
or
Patients with their FCDE randomised in ORACLE MS clinical trial who have received= 1 course of IMP (Cladribine Tablets or placebo).
2. Informed Consent
1. Medical Conditions:
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.
For the MRI sub-study:
1. Female Participants Who are pregnant
2. Patient taking Cladribine Tablets as part of another study at the time of the start of this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: To evaluate long-term mobility after treatment with an investigational medicinal product (IMP; Cladribine Tablets or placebo) as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials.;Timepoints: Proportion of study participants using a wheelchair (defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day) the majority of the time in the 3 months prior to Study Visit 1 for the CLARITY/CLARITY-EXT and ORACLE MS populations,;Measure: • Expanded Disability Status Scale (EDSS) score of 7.0 or higher (if available), or • Alternative clinical description data in medical records.
- Secondary Outcome Measures
Name Time Method