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ACTIVE NOT RECRUITING
NCT03653273
PHASE3

Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)

Sponsor: Rennes University Hospital

View on ClinicalTrials.gov

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

Interventions

OTHER

DMT withdrawal

Group 1 (DMT withdrawal) will not undergo any disease modifying treatments (DMT).

DRUG

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