Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05136976
PHASE3

Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

View on ClinicalTrials.gov

Summary

Anti-MAG neuropathy is a progressively disabling orphan rare disorder due to a monoclonal immunoglobulin M(IgM) gammopathy displaying reactivity toward MAG, a glycoprotein of the peripheral nervous system. Its prevalence is around 1/100000 and to date, no treatment has proven efficacy in this disease, including rituximab in 2 Randomized Controlled Trails(RCTs).

Official title: Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders:

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-06-29

Completion Date

2028-12

Last Updated

2025-11-24

Healthy Volunteers

No

Interventions

DRUG

Rituximab infusion

2 infusions of 1 gram of rituximab at a 2 week interval (day 1 followed by day 15).

DRUG

Placebo infusion

2 infusions of placebo at a 2 week interval.

DRUG

Premedications

Premedications prior to rituximab or placebo infusions: * IV Dexchlorpheniramine Maleate IV: 10 mg * IV Methylprednisolone: 40 mg * PO Paracetamol : 1 gram

Locations (15)

CHU Brest - La cavale blanche

Brest, France

CHU Grenoble - La tronche

Grenoble, France

CHU Lille - Roger Salengro

Lille, France

CHU Limoges - Dupuytren

Limoges, France

HCL lyon

Lyon, France

CHU La Timone - APHM

Marseille, France

CHU Nancy- Hôpital central

Nancy, France

Hôtel-Dieu et Hôpital GR Laënnec - CHU Nantes

Nantes, France

CHU Nice - Pasteur

Nice, France

APHP Pitié Salpêtrière

Paris, France

APHP - Kremlin-Bicêtre

Paris, France

CHU de Saint-Etienne

Saint-Etienne, France

CHU Strasbourg - Hautepierre

Strasbourg, France

CHU Toulouse - Pierre-Paul Riquet

Toulouse, France

CHU Tours - Bretonneau

Tours, France