Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP) (STOP-I-SEP)
Multiple Sclerosis
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, secondary progressive, disease modifying treatment, medico economic impact, treatment withdrawal
Eligibility Criteria
Inclusion Criteria:
- Patients > 50 years old;
- Secondary progressive phenotype for at least 3 years;
- Disease modifying therapy of MS for at least 3 years (interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, fingolimod, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, rituximab, ocrelizumab); Both patients with the same DMT or with successive DMTs can be included;
- No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan);
- EDSS≥3.
Concomitant medications with Fampridine are allowed throughout the study, provided they have been introduced at least 1 months before inclusion.
For Rituximab and Ocrelizumab, inclusion in STOP-I-SEP will be at 6 months from the last infusion to take into account the mode of action of these treatments and their specific administration scheme.
Exclusion Criteria:
- Patients treated with mitoxantrone or alemtuzumab, during the previous 3 years before inclusion;
- Patients treated with natalizumab during the year before inclusion;
- Change of disease modifying therapy of MS for less than a year
- Other neurological or systemic disease ;
- Incapacity to understand or sign the consent form ;
- Contraindication to MRI ;
- Pregnancy or breast-feeding ;
- Patient in another clinical trial
- Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (eg minors, protected adults, …).
Sites / Locations
- CHU AngersRecruiting
- CHU de Bordeaux
- CHU BrestRecruiting
- CH de Chartres
- CHU Clermont-FerrandRecruiting
- Hôpital Henri Mondor
- CHU Dijon
- CHU GrenobleRecruiting
- CH de Libourne
- CHU LilleRecruiting
- Hôpital Saint Vincent de PaulRecruiting
- Hospices Civils LyonRecruiting
- AP-HM
- CHU MontpellierRecruiting
- CHU Nancy
- CHU NantesRecruiting
- CHU NiceRecruiting
- CHU de Nîmes
- AP-HP (La Pitié Salpêtrière)Recruiting
- Fondation de Rothschild
- CH PoissyRecruiting
- CHU Poitiers
- CH QuimperRecruiting
- CHU RennesRecruiting
- CHU StrasbourgRecruiting
- CH de Foch
- CHU ToursRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DMT withdrawal
DMT continuation
DMT will be immediately stopped after randomization.These patients will be followed for 2 years.
The previously established therapy will be continued at the same dose during two years.