Cladribine Tablets: Evaluation in Aging MS Patients
The study is designed to observe the effectiveness and safety of Cladribine Tablets as a final treatment choice for aging patients with relapsing-remitting multiple sclerosis (RRMS) compared to continuing or discontinuing current therapies. The study plans to include about 150 patients and utilize dynamic propensity score matching for comparisons.
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Why it matters
Understanding the role of Cladribine in older MS patients who have had stable disease for years may inform treatment strategies and options available as they age.
What this does not prove
No results have been posted. The study is observational and it does not prove causation, as it is still in the planning phase, and findings are not yet available.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
- Trial registrationCladribine Tablets as an Exit Therapy Strategy ↗
Supporting passages (6)
study design"briefSummary": "The objective of the study is to evaluate the effectiveness of CladT, in terms of disease stability and safety, as the last treatment option in ageing MS patients vs treatment continuation and discontinuation This observational study will use database from local cohorts (from France, Belgium, Switzerland).
subjectsPatients included must meet the inclusion criteria: RRMS diagnosis for more than 10 years without secondary progression, no evidence of disease activity (no relapse, no new MRI lesion, no EDSS progression) for more than 5 years under a DMT, age≥ 45-year-old.\n\nAnalyses will be using dynamic propensity score to match patients who stopped treatment with patients who had the same probability of continuing / stopping current treatments but took CladT as exit therapy.
controlledPatients will be matched 1:1 using propensity score on gender, age, MS duration, time before last relapse, EDSS score, DMTs.\n\nThe study will use retrospectively collected data within the date frame from 06/30/25 to 06/30/26.\n\nApproximately 150 patients treated with cladribine will be identified and included in this study in 7 centers: Strasbourg, Lille, Montpellier, Nimes, Liège, Pelt, Lugano.",
primary endpoint"measure": "To evaluate the clinical activity during the 3 years of follow-up in patients switching to cladribine and continuing current DMT",
findings"briefSummary": "The objective of the study is to evaluate the effectiveness of CladT, in terms of disease stability and safety, as the last treatment option in ageing MS patients vs treatment continuation and discontinuation This observational study will use database from local cohorts (from France, Belgium, Switzerland).
limitationsPlanned enrolment and endpoints are not findings.
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