Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cladribine group |
| ||
| Continuing treatment group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cladribine | Drug | To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT | Proportion of patients with relapses* and time to event during the 2 years of follow-up in patients switching to cladribine and continuing current DMT | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and stopping current DMT | Proportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and stopping current DMT | 2 years |
| To evaluate the clinical activity during the 3 years of follow-up in patients switching to cladribine and continuing current DMT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This is a multicentric retrospective and controlled cohort with non-inferiority analysis. Patients will be matched 1:1 using propensity score on gender, age, MS duration, time before last relapse, EDSS score, DMTs.
The study will use retrospectively collected data within the date frame from 06/30/25 to 06/30/26.
Approximately 150 patients treated with cladribine will be identified and included in this study in 7 centers: Strasbourg, Lille, Montpellier, Nimes, Liège, Pelt, Lugano.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de neurologie - Hôpitaux Universitaires de Strasbourg | Strasbourg | 67000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017338 | Cladribine |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
Not provided
Not provided
Not provided
Not provided
Not provided
Proportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and continuing current DMT |
| 2 years |
| To evaluate the radiological activity during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT | Proportion of patients with new T2 lesions on brain MRI at 1 and 2 years in patients switching to cladribine, continuing current DMT and stopping DMT | 2 years |
| To evaluate the disability during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT | Proportion of patients with EDSS worsening** after 2 years in patients switching to cladribine, continuing current DMT and stopping DMT | 2 years |
| To evaluate the risk of serious adverse events in patients switching to cladribine and continuing current DMT | Proportion of patients with any serious adverse events after 2 years in patients switching to cladribine and continuing current DMT | 2 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |