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Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)
Sponsor: Rennes University Hospital
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.
Official title: Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2019-01-24
Completion Date
2027-07
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (27)
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