EUCTR2018-001292-21-FR
Active, not recruiting
Phase 1
Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years
CHU de Rennes0 sites250 target enrollmentJune 5, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Secondary Progressive Multiple Sclerosis
- Sponsor
- CHU de Rennes
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients \> or \= 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, fingolimod, natalizumab, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil); Both patients with the same DMT or with successive DMTs during 3 years 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\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 225
Exclusion Criteria
- •\- Patients treated with mitoxantrone, alentuzumab, rituximab or ocrelizumab during the previous 3 years 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, …).
Outcomes
Primary Outcomes
Not specified
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