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

NCT05136976 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-24

No results posted yet for this study

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).

Conditions

  • Anti-MAG Neuropathy

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Anne-Laure KAMINSKY, MD · CHU de Saint-Etienne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136976 on ClinicalTrials.gov