EFFRITE
What it found
The main measure did not show a significant benefit.
“OPN level remained stable in CSF at each time point, whereas NFL had slightly decreased (-8.7%) at day 21 ( p = 0.02).”Read by software from the paper's abstract
Change in levels of CSF biomarkers of inflammation (osteopontin) · each time point
Read by software from the paper's abstract
What was tested
Treatment tested
- Rituximab
B-lymphocyte antigen CD20 binding agent
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
Change in osteopontin level in CSF
at day 4, day 21, day 180
Blood or spinal fluid markers
Other measures (3)
Change in Tumor Necrosis Factor alpha level in CSF
day 4, day 21, day 180
Blood or spinal fluid markersChange in IgG synthesis in CSF
day 4, day 21, day 180
Blood or spinal fluid markersChange in neurofilament level in CSF
day 4, day 21, day 180
Blood or spinal fluid markers
Who could take part
Progressive MS · 45 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Model-Informed Precision Dosing of Protein Kinase Inhibitors: Evaluation of Model-Averaging and Flattened Priors Methods.Clin Pharmacokinet · 2026
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.
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History
Started
Nov 2015
Main results due
Feb 2019
Finished
Sept 2019
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