Rituximab treatment for patients with anti-MAG neuropathy who are likely to respond
Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders:
This study is testing if rituximab can help people with anti-MAG neuropathy who have had the disease for less than two years and have high anti-MAG levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Drugs / interventions | rituximab |
| Locations | 15 sites (Brest and 14 other locations) |
| Trial ID | NCT05136976 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of rituximab in patients diagnosed with anti-MAG neuropathy who exhibit specific characteristics indicating a higher likelihood of response. The study focuses on individuals with a disease duration of less than two years and an anti-MAG titre above 10,000 Buhlmann Titer Units (BTU). By utilizing the Inflammatory Rasch-built Overall Disability Scale (I-RODS) as the primary outcome measure, the trial aims to detect meaningful clinical changes in this targeted patient population. The study is designed to address previous methodological issues encountered in earlier trials by selecting a more defined cohort of patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with anti-MAG neuropathy who have a disease duration of less than two years and an anti-MAG titre of 10,000 BTU or more.
Not a fit: Patients with a longer disease duration or lower anti-MAG titres may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant improvement in the quality of life for patients suffering from anti-MAG neuropathy.
How similar studies have performed: Previous studies have shown mixed results with rituximab in anti-MAG neuropathy, making this approach both novel and necessary to refine treatment strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Disease duration of 5 years or less and documented clinical worsening (clinical or ENMG or disability) over the past 24 months * IgM gammopathy, either MGUS or Waldenstrom Macroglobulinemia (WM) * Demyelinating polyneuropathy according to European Federation of Neurological Societies/Peripheral Nerve Society guidelines for chronic inflammatory demyelinating polyneuropathy on nerve conduction studies. * Anti-MAG titre of 10 000 BTU or more * Total INCAT score of 1 point or more at baseline * Absence of immunoglobulin treatment within 3 months prior to inclusion. * Absence of immunosuppressive therapy within 6 months prior to inclusion, including steroid therapy of 2 months or more as part of the management of neuropathy. * Negative β-human chorionic gonadotropin (HCG) in women of childbearing potential * Women of childbearing potential must agree to use contraception for 365 days following administration of rituximab. Exclusion Criteria: * \- Unable to give informed consent * History of severe allergic or anaphylactic reaction to chimeric monoclonal antibody * Hypersensitivity known to one of the compounds of polaramine or methylprednisolone * Previous treatment with rituximab * Diseases known to cause polyneuropathy (e.g. diabetes, uncontrolled thyroid disease, vitamin B1 or B12 deficiency, renal (GFR \< 60ml ml/min/1,73 m2- Modification of Diet in Renal Disease (MDRD) formula) or liver disorder, myeloma, amyloidosis, cryoglobulinemia) * Indication of specific immunosuppressive therapy for WM * Significant uncontrolled disease at baseline such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal or any other significant disease that may prevent patient from participating in the study * Congestive heart failure (NYHA III or IV) * Known active bacterial, viral, fungal mycobacterial infection * History or known presence of recurrent or chronic infection (e.g. viral hepatitis, HIV syphilis, tuberculosis). * History of cancer, including solid tumors and haematological malignancies (except basal cell and in situ squamous carcinoma of the skin, in situ carcinoma of the cervix of the uterus that have been excised and resolved, with documented clear margins on pathology) * History of alcohol (more than two drinks a day for a woman, more than 4 glasses a day for a man \[World Health Organization (WHO) definition\]) or other drug abuse within 6 months prior to randomization * History or currently active primary or secondary immunodeficiency * White blood cell count \< 1500/mm3 or platelet count \< 75 000/mm3 * Angle closure glaucoma, * Urinary retention related to urethroprostatic disorders, * Uncontrolled psychotic disorders, * Severe liver failure, * Recent vaccination with live vaccines (\<3months) and vaccination with live virus vaccines is not recommended during the overall study period.
Where this trial is running
Brest and 14 other locations
- CHU Brest - La cavale blanche — Brest, France (Recruiting)
- CHU Grenoble - La tronche — Grenoble, France (Recruiting)
- CHU Lille - Roger Salengro — Lille, France (Recruiting)
- CHU Limoges - Dupuytren — Limoges, France (Recruiting)
- HCL lyon — Lyon, France (Recruiting)
- CHU La Timone - APHM — Marseille, France (Recruiting)
- CHU Nancy- Hôpital central — Nancy, France (Recruiting)
- Hôtel-Dieu et Hôpital GR Laënnec - CHU Nantes — Nantes, France (Recruiting)
- CHU Nice - Pasteur — Nice, France (Recruiting)
- APHP Pitié Salpêtrière — Paris, France (Recruiting)
- APHP - Kremlin-Bicêtre — Paris, France (Recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Recruiting)
- CHU Strasbourg - Hautepierre — Strasbourg, France (Recruiting)
- CHU Toulouse - Pierre-Paul Riquet — Toulouse, France (Recruiting)
- CHU Tours - Bretonneau — Tours, France (Recruiting)
Study contacts
- Principal investigator: Anne-Laure KAMINSKY, MD — CHU de Saint-Etienne
- Study coordinator: Anne-Laure KAMINSKY, MD
- Email: a.laure.kaminsky@chu-st-etienne.fr
- Phone: (0)4 77 82 95 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.