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

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.

Conditions

• Multiple Sclerosis

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.

Sponsors & Collaborators

• Rennes University Hospital

  lead OTHER

Principal Investigators

• Anne KERBRAT, Dr · CHU Rennes - National Headache Center

• Clarisse SCHERER-GAGOU, Dr · University Hospital, Angers

• Jean PELLETIER, Pr · AP-HM

• Céline LOUAPRE, Dr · AP-HP La pitié Salpêtrière

• Aurore JOURDAIN, Dr · CHU Brest

• Pierre CLAVELOU, Pr · University Hospital, Clermont-Ferrand

• Thibault MOREAU, Pr · CHU Dijon

• Olivier CASEZ, Dr · University Hospital, Grenoble

• Hélène ZEPHIR, Pr · CHU Lille

• Sandra VUKUSIC, Pr · Hospices Civils de Lyon

• Pierre LABAUGE, Pr · University Hospital, Montpellier

• Guillaume MATHEY, Dr · CHU NANCY

• David LAPLAUD, Pr · Nantes University Hospital

• Christine LEBRUN-FRENAY, Pr · CHU NICE

• Olivier HEINZLEF, Dr · CH Poissy

• Jean-Philippe NEAU, Pr · CHU Poitiers

• Marc COUSTANS, Dr · CH Quimper

• Jérôme DE SEZE, Pr · CHU Strasbourg

• Anne-Marie GUENNOC, Dr · CHU Tours

• Caroline BENSA-KOSCHER, Dr · Fondation de Rothschild

• Eric THOUVENOT, Pr · Centre Hospitalier Universitaire de Nīmes

• Alain CREANGE, Pr · CH HENRI MONDOR

• Arnaud KWIATKOWSKI, Dr · Hôpital Saint Vincent de Paul

• Aurelie RUET, Pr · University Hospital, Bordeaux

• Jérôme GRIMAUD, Dr · CH de Chartres

• Maia TCHIKVILADZE, Dr · CH Foch

• Philippe CASENAVE, Dr · CH de Libourne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-24

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• France

Study Locations