Intrathecal Rituximab in Progressive Multiple Sclerosis

• Status: Completed
• Trial end date: 2019-09-02
• Target enrollment: 0
• Participant gender: All

Summary

The goal of investigators is to study the kinetics of action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets in progressive MS patients. Various markers of central nervous system inflammation (osteopontin, Tumor Necrosis Factor α, IgG secretion) and neurodegeneration (neurofilament) are studied at multiple time-points, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier de PAU
• Collaborator: University Hospital, Bordeaux
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

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.

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);

• Earlier treatment with rituximab;

• Dementia or severe psychiatric disorder.