Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Secondary Progressive Multiple Sclerosis; MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2018-001292-21-FR
• Lead Sponsor: CHU de Rennes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 250

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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, …).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified