NCT05136976 Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
| NCT ID | NCT05136976 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Anti-MAG Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-06-29 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2023-06-29 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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.
Contact & Investigator
Anne-Laure KAMINSKY, MD
PRINCIPAL INVESTIGATOR
CHU de Saint-Etienne
Frequently Asked Questions
Who can join the NCT05136976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anti-MAG Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05136976 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT05136976 currently recruiting?
Yes, NCT05136976 is actively recruiting participants. Contact the research team at a.laure.kaminsky@chu-st-etienne.fr for enrollment information.
Where is the NCT05136976 trial being conducted?
This trial is being conducted at Brest, France, Grenoble, France, Lille, France, Limoges, France and 11 additional locations.
Who is sponsoring the NCT05136976 clinical trial?
NCT05136976 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Anne-Laure KAMINSKY, MD at CHU de Saint-Etienne. The trial plans to enroll 90 participants.