Rituximab Treatment for Anti-Myelin Associated Glycoprotein Neuropathy in Patients Likely to Respond Well Phase 3 Randomized, Double-Blind, Placebo-Controlled Study

What this Trial Is About

Anti-MAG neuropathy is a rare and progressively disabling disorder caused by a monoclonal immunoglobulin M IgM gammopathy targeting MAG, a protein in the peripheral nervous system. The prevalence is about 1 in 100,000, and no treatment, including rituximab, has proven effective in prior randomized controlled trials. This trial focuses on patients with characteristics suggesting better response to rituximab, such as shorter disease duration and higher anti-MAG antibody levels. Participants will be randomly assigned to receive either rituximab or a placebo. Rituximab is given as two infusions of 1 gram each, spaced two weeks apart, with premedications including dexchlorpheniramine, methylprednisolone, and paracetamol before each infusion. Both groups receive the same premedication regimen to prepare for the infusions. During the 12-month study, participants will be evaluated using the Inflammatory Rasch-built Overall Disability Scale I-RODS at baseline and after 12 months, along with various other tests such as disability scores, walking and hand function tests, nerve studies, and monitoring for side effects. Researchers will also measure anti-MAG antibody levels. The study will monitor safety and treatment effects throughout the year-long participation period.

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