Cladribine Tablets as an Exit Therapy Strategy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cladribine.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cladribine Tablets as an Exit Therapy Strategy: Alternative to Continuing Treatment and Plain Treatment Discontinuation in Ageing Stable RMS Patients
Overview
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.
Interventions
- Drug Cladribine
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT
Primary outcome measures
- To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT [Time frame: 2 years]
Secondary outcome measures (5)
- To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and stopping current DMT [Time frame: 2 years]
- To evaluate the clinical activity during the 3 years of follow-up in patients switching to cladribine and continuing current DMT [Time frame: 2 years]
- To evaluate the radiological activity during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT [Time frame: 2 years]
- To evaluate the disability during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT [Time frame: 2 years]
- To evaluate the risk of serious adverse events in patients switching to cladribine and continuing current DMT [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Service de neurologie - Hôpitaux Universitaires de Strasbourg — Strasbourg
Identifiers
NCT: NCT06887426 · 9628