Cladribine Tablets as an Exit Therapy Strategy

Study acronym: CLADREXIT
StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Notable Start date changed from estimate of Jun 2025 to Oct 17, 2025 Show 5 more changesShow less
    • Completed without a posted recruiting period
    • Primary completion date changed from estimate of Dec 2025 to Jun 1, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site contact updated
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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). Patients 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. Analyses 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. Patients with a minimum of 24 months follow up will be included. The investigators will ensure that CladT provide disease stability compared to treatment continuation / discontinuation in ageing MS patients by measuring: * the percentage of patients free of relapse, and time to first relapse, defined as the appearance, recurrence, or aggravation of neurological symptoms for a period of at least 24 hours without fever. * the percentage of patients free of EDSS progression confirmed for at least 6 months and until the end of patient follow up. * the percentage of patients free of MRI activity, defined as new or enlarged T2 lesions compared with the previous brain MRI scan or gadolinium enhancing T1 lesions.
Trial Details
NCT Number NCT06887426
Lead Sponsor University Hospital, Strasbourg, France
Conditions
(from sponsor)
Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Related terms Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov