Service de neurologie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000, France
NCT Number: NCT06887426
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 opening soon.
Get Notified45 year and older
All sexes
Observational
Strasbourg, 67000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
Proportion of patients with EDSS worsening** after 2 years in patients switching to cladribine, continuing current DMT and stopping DMT
Time frame: 2 years
Proportion of patients with any serious adverse events after 2 years in patients switching to cladribine and continuing current DMT
University Hospital, Strasbourg, France
Other
Cladribine Tablets as an Exit Therapy Strategy: Alternative to Continuing Treatment and Plain Treatment Discontinuation in Ageing Stable RMS Patients
Acronym: CLADREXIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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