Study the action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action in patients with Progressive Multiple Sclerosis.
Phase 1
- Conditions
- Patients included in our study suffer from a progressive form of Multiple sclerosis and will be treated by intravenous and intrathecal rituximab, with intravenous methylprednisolone.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-005493-11-FR
- Lead Sponsor
- Centre Hospitalier de Pau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Age =45 years, male or female ;
Secondary or primary progressive MS, in progressive phase since >2 years ;
EDSS =6.0 ;
Absence of alternative therapy.
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Relapsing-remitting phase of MS;
Contraindication to MRI, lumbar puncture, Trendelenburg position ;
Active infection or immunosuppressive state or treatment (actual or less than 6 months);
Severe heart failure or uncontrolled severe heart disease.
Earlier treatment with rituximab;
Dementia or severe psychiatric disorder.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method