Intrathecal Rituximab in Progressive Multiple Sclerosis

Sponsor
Centre Hospitalier de PAU
Study ID
NCT02545959
Phase
PHASE2
Status
Completed

Conditions

  • Multiple Sclerosis, Chronic Progressive
  • Nervous System Diseases

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab IT — DRUG
    CSF injection of intrathecal rituximab (20mg)
  • methylprednisolone IV — DRUG
    blood infusion of methylprednisolone IV (120mg)
  • Rituximab IV — DRUG
    Blood infusion of rituximab (375mg/m2)

Study Details

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.

Key Dates

Start date
Nov 30, 2015
Status verified
Apr 2019
Primary completion
Feb 22, 2019
Completion
Sep 2, 2019

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    receive a single pulse of methylprednisolone IV (120mg)
  • Experimental: Rituximab IT group
    receive a single intrathecal infusion of rituximab (with IV methylprednisolone 120mg to avoid side effect)
  • Experimental: Rituximab IT + IV group
    receive Rituximab IT as previous and Rituximab IV (375mg/m2) the same day

Primary Outcome Measure

Change in osteopontin level in CSF [ Time Frame: at day 4, day 21, day 180 ]

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