drugset / Trial / NCT05136976
Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
Phase 3
Recruiting
90 enrolled
University Hospital of Saint-Etienne
Ministry of Health, France · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2023-06-29
- Primary completion
- 2027-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 1 g | — |
| Comparator | Acetaminophen | Small molecule | 1 g | Oral |
| Comparator | Dexchlorpheniramine | Unknown | 10 mg | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 40 mg | Intravenous |