Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)
Condition(s) studied
Investigational drug(s) / intervention(s)
DMT withdrawal: Group 1 (DMT withdrawal) will not undergo any disease modifying treatments (DMT).
DMT continuation: Group 2 (DMT continuation) may undergo the DMT . The therapy continued in this research is the one previously established, at the same dose, not implying additional precautions for use.
Study summary
Further controlled and randomized prospective studies in Multiple sclerosis, analyzing the potential impact of treatment discontinuation on disability progression, focal disease activity and quality of life are needed. The optimum patient age and duration of inactive SPMS before treatment withdrawal and the monitoring procedures also need to be specified, the ultimate goal being to provide evidence-based recommendations for clinical practice. Following the previous retrospective experience, we decided to drive a multicenter prospective study in France based on the hypothesis that stopping disease modifying therapy will not induce an increased risk of disability progression and relapse in selected SPMS patients (older patients without lesion activity) but will improve the quality of life and may reduce treatment-related costs.
Eligibility
Primary outcome measure(s)
- Disability progression measured by EDSS — 24 months
Disability progression measured by the Percentage of patients experiencing disability progression (confirmed at 6 months) at 2 years. Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was more than 5.5.
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Angers | Angers | France | |
| CHU de Bordeaux | Bordeaux | France | |
| CHU Brest | Brest | France | |
| CH de Chartres | Chartres | France | |
| CHU Clermont-Ferrand | Clermont-Ferrand | France | |
| Hôpital Henri Mondor | Créteil | France | |
| CHU Dijon | Dijon | France | |
| CHU Grenoble | Grenoble | France | |
| CH de Libourne | Libourne | France | |
| CHU Lille | Lille | France | |
| Hôpital Saint Vincent de Paul | Lille | France | |
| Hospices Civils Lyon | Lyon | France | |
| AP-HM | Marseille | France | |
| CHU Montpellier | Montpellier | France | |
| CHU Nancy | Nancy | France | |
| CHU Nantes | Nantes | France | |
| CHU Nice | Nice | France | |
| CHU de Nîmes | Nîmes | France | |
| AP-HP (La Pitié Salpêtrière) | Paris | France | |
| Fondation de Rothschild | Paris | France | |
| CH Poissy | Poissy | France | |
| CHU Poitiers | Poitiers | France | |
| CH Quimper | Quimper | France | |
| CHU Rennes | Rennes | France | |
| CHU Strasbourg | Strasbourg | France | |
| CH de Foch | Suresnes | France | |
| CHU Tours | Tours | France |
More Rennes University Hospital trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03653273 on ClinicalTrials.gov ↗ ← All trials in France