drugset / Trial / NCT02545959
Intrathecal Rituximab in Progressive Multiple Sclerosis
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-11-30
- Primary completion
- 2019-02-22
- Completion
- 2019-09-02
Publications
- Background Bonnan M, Ferrari S, Bertandeau E, Demasles S, Krim E, Miquel M, Barroso B. Intrathecal rituximab therapy in multiple sclerosis: review of evidence supporting the need for future trials. Curr Drug Targets. 2014;15(13):1205-14. doi: 10.2174/1389450115666141029234644.
- Background Bonnan M. Intrathecal immune reset in multiple sclerosis: exploring a new concept. Med Hypotheses. 2014 Mar;82(3):300-9. doi: 10.1016/j.mehy.2013.12.015. Epub 2013 Dec 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 20 mg | Intrathecal |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intrathecal |
| Background | Methylprednisolone | Other / unclassified | 120 mg | Intravenous |