NCT02545959: EFFRITE

Intrathecal Rituximab in Progressive Multiple Sclerosis

Completed Phase 2 Last updated 3 October 2019

What this trial tests

Phase 2 trial testing Rituximab IT in Multiple Sclerosis, Chronic Progressive in 10 participants. Completed in 2 September 2019.

Timeline

30 November 2015

Primary endpoint
22 February 2019

2 September 2019

Quick facts

Lead sponsor	Centre Hospitalier de PAU
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	30 November 2015
Primary completion	22 February 2019
Estimated completion	2 September 2019
Sites	1 location across France

Drugs / interventions tested

• Rituximab IT — full drug profile →
• methylprednisolone IV — full drug profile →
• Rituximab IV — full drug profile →

Conditions studied

• Multiple Sclerosis, Chronic Progressive — all drugs for Multiple Sclerosis, Chronic Progressive →
• Nervous System Diseases — all drugs for Nervous System Diseases →

Sponsor

Centre Hospitalier de PAU

Who can join

45 and older, any sex, with Multiple Sclerosis, Chronic Progressive or Nervous System Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting B cells in relapsing-remitting multiple sclerosis: from pathophysiology to optimal clinical management.
   Bittner S, Ruck T, Wiendl H, Grauer OM, et al · · 2017 · cited 47× · PMID 28450895 · DOI 10.1177/1756285616666741
2. What Have Failed, Interrupted, and Withdrawn Antibody Therapies in Multiple Sclerosis Taught Us?
   Krämer J, Wiendl H. · · 2022 · cited 14× · PMID 35794296 · DOI 10.1007/s13311-022-01246-3
3. Rituximab for people with multiple sclerosis.
   Filippini G, Kruja J, Del Giovane C. · · 2021 · cited 11× · PMID 34748215 · DOI 10.1002/14651858.cd013874.pub2
4. No Early Effect of Intrathecal Rituximab in Progressive Multiple Sclerosis (EFFRITE Clinical Trial).
   Bonnan M, Ferrari S, Courtade H, Money P, et al · · 2021 · cited 11× · PMID 33763241 · DOI 10.1155/2021/8813498
5. Targeting Immune Modulators in Glioma While Avoiding Autoimmune Conditions.
   Bitar L, Schumann U, König R, Zipp F, et al · · 2021 · cited 4× · PMID 34298735 · DOI 10.3390/cancers13143524
6. Focal cortical atrophy following transient meningeal enhancement in a progressive multiple sclerosis.
   Bonnan M, Money P, Desblache P, Marasescu R, et al · · 2021 · cited 3× · PMID 32995987 · DOI 10.1007/s10072-020-04764-0
7. Imaging Outcomes for Phase 2 Trials Targeting Compartmentalized Inflammation.
   Gaitán MI, Marquez RV, Ayerbe J, Reich DS. · · 2024 · cited 1× · PMID 39658905 · DOI 10.1177/13524585241301303
8. Model-Informed Precision Dosing of Protein Kinase Inhibitors: Evaluation of Model-Averaging and Flattened Priors Methods.
   Le Louedec F, Morvan L, Mourey L, Maillard M, et al · · 2026 · PMID 41801644 · DOI 10.1007/s40262-026-01628-2