NCT06887426Completed
Cladribine Tablets as an Exit Therapy Strategy
Cladribine Tablets as an Exit Therapy Strategy: Alternative to Continuing Treatment and Plain Treatment Discontinuation in Ageing Stable RMS Patients
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 450 (actual)
- First submitted
- 13 Mar 2025
- Start date
- 17 Oct 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Multiple sclerosis
- NCT number
- NCT06887426
What you commit to
- Study type: Observational
- Participants enrolled: 450
- From 17 Oct 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Progressive form of MS
- Patients without DMT
- EDSS score ≥6.5
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de neurologie - Hôpitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.