drugset / Trial / NCT02545959

Intrathecal Rituximab in Progressive Multiple Sclerosis

NCT02545959 ↗

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 20 mg Intrathecal
Subject Rituximab Monoclonal antibody 375 mg/m2 Intrathecal
Background Methylprednisolone Other / unclassified 120 mg Intravenous