Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting Multiple Sclerosis Patients Aged 55 and Over (TWINS : Therapies Withdrawal IN Relapsing Multiple Sclerosis)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

June 30, 2029

Conditions
Relapsing-remitting Multiple Sclerosis (RRMS)
Interventions
DRUG

treatment withdrawal

Patients will STOP their DMT

DRUG

Usual DMT continuation

Patients will continue their DMT during the trial as usual : Interferon-β (IFN-β), glatiramer acetate, dimethyl fumarate, teriflunomide or diroximel fumarate

OTHER

MRI

Cerebral+spinal cord enhanced MRI (M0) Cerebral enhanced MRI (M6, Relapse early visit) Unenhanced cerebral MRI (M12, M18, M24, Relapse distant visit

BEHAVIORAL

Quality of Life questionnaires

EQ-5D5L: EuroQol-5-Dimension 5 levels Burden of Treatment Questionnaire (BTQ self-administered questionnaires) Hospital Anxiety and Depression (HAD) questionnaire

OTHER

Disability evaluation tests

EDSS: Expanded Disability Status Scale 25Foot/Walk 9-HPT:Nine Hole Peg Test

Trial Locations (22)

13005

Assistance Publique des Hôpitaux de Marseille (APHM)-Hôpital La Timone Adultes, Marseille

14033

CHU de Caen-Hôpital Côte de Nacre, Caen

21079

CHU de Dijon-Hôpital du Bocage, Dijon

30029

CHU de Nîmes, Nîmes

33076

CHU de Bordeaux-Hôpital Pellegrin, Bordeaux

34295

CHU de Montpellier-Hôpital G. De Chauliac, Montpellier

35033

CHU de Rennes-C.H.R. Pontchaillou, Rennes

37044

CHU de Tours, Tours

38700

CHU de Grenoble Alpes, La Tronche

54035

CHU de Nancy -Hôpital Central, Nancy

59020

Groupement des Hôpitaux de l'Institut Catholique de Lille Hôpital Saint Vincent de Paul, Lille

59037

CHU de Lille-Hôpital Roger Salengro, Lille

63003

CHU de Clermont-Ferrand-Hôpital Gabriel Montpied, Clermont-Ferrand

67000

Les Hôpitaux Universitaires de Strasbourg, Strasbourg

75013

Assistance Publique des Hôpitaux de Paris (APHP)-Hôpital Pitié-Salpêtrière, Paris

75019

Fondation Ophtalmologique Rothschild, Paris

76038

CHU de Rouen-Hôpital Charles Nicolle, Rouen

87042

CHU de Limoges-Hôpital Dupuytren, Limoges

94010

Assistance Publique des Hôpitaux de Paris (APHP)-Hôpital Henri Mondor, Créteil

95500

CH de Gonesse, Gonesse

06002

CHU de Nice-Hôpital Pasteur, Nice

44 093

CHU Nantes -CIC de Neurologie, Saint-Herblain

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

University Hospital, Strasbourg, France

OTHER