NCT05136976

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

However these trials have included unselected anti-MAG patients and methodological issues have been raised. In COFRAMAG study, the largest cohort worldwide of anti-MAG patients, predictors of clinical response to rituximab were identified through analysis of 92 treated patients: shorter disease duration and anti-MAG titre above 10000 BTU. Thus this study will focus on rituximab efficacy in a subset of patients with disease duration of less than 2 years and anti-MAG titre above 10000 Buhlmann Titer Units (BTU). The investigators selected Inflammatory Rasch-built Overall Disability Scale (I-RODS) as primary outcome measure because its responsiveness was proven higher than INCAT/ Overall Neuropathy Limitation Score (ONLS) scales to detect clinical meaningful changes in newly treated patients with inflammatory neuropathies.

Conditions

• Anti-MAG Neuropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-29
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2021-11-30
• Last updated: 2025-11-24

Locations

15 sites across 1 country: France