Actively Recruiting
Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-11-24
90
Participants Needed
15
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Disease duration of 5 years or less with documented worsening over the past 24 months
- Presence of IgM gammopathy (MGUS or Waldenstrom Macroglobulinemia)
- Diagnosis of demyelinating polyneuropathy based on nerve conduction studies
- Anti-MAG antibody titre of 10,000 BTU or more
- Total INCAT disability score of 1 point or more at baseline
- No immunoglobulin treatment within 3 months before inclusion
- No immunosuppressive therapy, including steroids for 2 months or more, within 6 months before inclusion
- Negative beta-human chorionic gonadotropin (HCG) test in women of childbearing potential
- Women of childbearing potential agree to use contraception for 365 days after rituximab administration
You will not qualify if you...
- Unable to give informed consent
- History of severe allergic or anaphylactic reaction to chimeric monoclonal antibodies
- Known hypersensitivity to polaramine or methylprednisolone
- Previous treatment with rituximab
- Presence of diseases causing polyneuropathy such as diabetes, uncontrolled thyroid disease, vitamin B1 or B12 deficiency, renal or liver disorders, myeloma, amyloidosis, or cryoglobulinemia
- Need for specific immunosuppressive therapy for Waldenstrom Macroglobulinemia
- Significant uncontrolled diseases including cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, or others that may affect participation
- Congestive heart failure classified as NYHA III or IV
- Active bacterial, viral, fungal, or mycobacterial infections
- History or presence of recurrent or chronic infections like viral hepatitis, HIV, syphilis, or tuberculosis
- History of cancer except certain skin or cervical cancers that have been fully treated
- History of alcohol or drug abuse within 6 months before randomization
- History or presence of primary or secondary immunodeficiency
- Low white blood cell or platelet counts
- Angle closure glaucoma
- Urinary retention related to urethroprostatic disorders
- Uncontrolled psychotic disorders
- Severe liver failure
- Recent vaccination with live vaccines within 3 months or live virus vaccinations during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive 2 infusions of rituximab or placebo at a 2 week interval, with premedications given before each infusion.
2 infusion visits (in-person) over 2 weeks
Duration - 12 months
Participants are monitored with assessments to evaluate treatment effects and safety over 12 months.
Visits at baseline, 6 months, and 12 months
Trial Site Locations
Total: 15 locations
1
CHU Brest - La cavale blanche
Brest, France, 29200
Actively Recruiting
2
CHU Grenoble - La tronche
Grenoble, France, 38700
Actively Recruiting
3
CHU Lille - Roger Salengro
Lille, France, 59037
Actively Recruiting
4
CHU Limoges - Dupuytren
Limoges, France, 87170
Actively Recruiting
5
HCL lyon
Lyon, France, 69002
Actively Recruiting
6
CHU La Timone - APHM
Marseille, France, 13915
Actively Recruiting
7
CHU Nancy- Hôpital central
Nancy, France, 54035
Actively Recruiting
8
Hôtel-Dieu et Hôpital GR Laënnec - CHU Nantes
Nantes, France
Actively Recruiting
9
CHU Nice - Pasteur
Nice, France, 06031
Actively Recruiting
10
APHP Pitié Salpêtrière
Paris, France, 75651
Actively Recruiting
11
APHP - Kremlin-Bicêtre
Paris, France, 94270
Actively Recruiting
12
CHU de Saint-Etienne
Saint-Etienne, France
Actively Recruiting
13
CHU Strasbourg - Hautepierre
Strasbourg, France, 67091
Actively Recruiting
14
CHU Toulouse - Pierre-Paul Riquet
Toulouse, France, 31059
Actively Recruiting
15
CHU Tours - Bretonneau
Tours, France, 37044
Actively Recruiting
Research Team
A
Anne-Laure KAMINSKY, MD
C
Carine LABRUYERE, CRA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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