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Not yet recruitingN/A

Cladribine Tablets as an Exit Therapy Strategy

NCT06887426 · CLADREXIT · University Hospital, Strasbourg, France

Closed to entry
Status
Not accepting participants
Not applicable
Phase
450
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT

    Measured over 2 years

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

45 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Patient ≥45-year-old with RRMS * Disease duration ≥10 years * No evidence of disease activity ≥5 years under DMT * EDSS score between 0 and 6.0 included Exclusion Criteria: * Progressive form of MS * Patients without DMT * EDSS score ≥6.5

Where

1 study site

FacilityCityRegionCountry
Service de neurologie - Hôpitaux Universitaires de StrasbourgStrasbourgFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06887426 on ClinicalTrials.gov →

Last updated in the registry 2025-06-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits