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Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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
Conditions
Interventions
Rituximab infusion
2 infusions of 1 gram of rituximab at a 2 week interval (day 1 followed by day 15).
Placebo infusion
2 infusions of placebo at a 2 week interval.
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