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Intrathecal Rituximab in Progressive Multiple Sclerosis

NCT02545959 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-10-03

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Chronic Progressive
  • Nervous System Diseases

Interventions

DRUG

Rituximab IT

CSF injection of intrathecal rituximab (20mg)

DRUG

methylprednisolone IV

blood infusion of methylprednisolone IV (120mg)

DRUG

Rituximab IV

Blood infusion of rituximab (375mg/m2)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    collaborator OTHER

  • Centre Hospitalier de PAU

    lead OTHER

Principal Investigators

  • Mickael Bonnan, MD · CH Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-02-22
Completion
2019-09-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545959 on ClinicalTrials.gov