Status:
ACTIVE_NOT_RECRUITING
Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)
Lead Sponsor:
Rennes University Hospital
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 o...
Detailed Description
Multiple sclerosis (MS) usually evolves over decades and can present several phenotypes. Approximately 85% of newly diagnosed Multiple Sclerosis (MS) patients present the Relapsing-Remitting MS (RRMS)...
Eligibility Criteria
Inclusion Criteria:
- Patients > 50 years old;
- Secondary progressive phenotype for at least 3 years; The secondary progressive phenotype will be defined as progressive deterioration of disability not due to relapse, with an increase of at least 1 EDSS point since the beginning of the progressive phase (or 0.5 EDSS point if EDSS score ≥ 5.5).
- Disease modifying therapy of MS for at least 3 years (interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, rituximab, ocrelizumab); Both patients with the same DMT or with successive DMTs during 3 years can be included. It is important to note that patients could have been treated with fingolimod or natalizumab 2 or 3 years before inclusion, but not during the year before inclusion ;
- 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.
Natalizumab and fingolimod during the year before inclusion were excluded because of the risk of recurrence of inflammatory activity or even rebound of inflammatory activity after withdrawal.
Both patients with the same DMT or with successive DMTs during 3 years can be included, as for example, cyclophosphamide is used for 1 or 2 years, sometimes followed by mycophenolate mofetil.
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 or fingolimod 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, …).
Key Trial Info
Start Date :
January 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03653273
Start Date
January 24 2019
End Date
July 1 2027
Last Update
March 30 2026
Active Locations (27)
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1
CHU Angers
Angers, France
2
CHU de Bordeaux
Bordeaux, France
3
CHU Brest
Brest, France
4
CH de Chartres
Chartres, France