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
283 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 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
Official 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 clinical worsening in the past 24 months
- Presence of IgM gammopathy, including MGUS or Waldenstrom Macroglobulinemia
- Diagnosis of demyelinating polyneuropathy based on nerve conduction studies
- Anti-MAG antibody titre of 10,000 BTU or greater
- Total INCAT disability score of 1 point or more at baseline
- No immunoglobulin treatment within 3 months before entering the study
- No immunosuppressive therapy within 6 months before entering the study, including steroids used for 2 months or more for neuropathy
- Negative pregnancy test for women who can become pregnant
- Agreement to use contraception for 365 days after rituximab administration for women of childbearing potential
You will not qualify if you...
- Unable to give informed consent
- History of severe allergic or anaphylactic reaction to chimeric monoclonal antibodies
- Known allergy to polaramine or methylprednisolone
- Previous treatment with rituximab
- Diseases causing polyneuropathy such as diabetes, uncontrolled thyroid disease, vitamin B1 or B12 deficiency, kidney or liver disorders, myeloma, amyloidosis, or cryoglobulinemia
- Need for specific immunosuppressive therapy for Waldenstrom Macroglobulinemia
- Significant uncontrolled diseases including cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal conditions that prevent study participation
- Congestive heart failure classified as NYHA III or IV
- Active bacterial, viral, fungal, or mycobacterial infections
- History or ongoing chronic infections such as viral hepatitis, HIV, syphilis, or tuberculosis
- History of cancer except certain non-invasive skin or cervical cancers fully treated
- History of alcohol abuse or drug abuse within 6 months before randomization
- Primary or secondary immunodeficiency currently or in the past
- Low white blood cell count below 1500/mm3 or platelet count below 75,000/mm3
- Angle closure glaucoma
- Urinary retention related to urethroprostatic disorders
- Uncontrolled psychotic disorders
- Severe liver failure
- Recent live vaccinations within 3 months or live virus vaccines not recommended during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Carine LABRUYERE, CRA
CONTACT
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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