Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders

Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Study ID
NCT05136976
Phase
PHASE3
Status
Recruiting
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Conditions

  • Anti-MAG Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab infusion — DRUG
    2 infusions of 1 gram of rituximab at a 2 week interval (day 1 followed by day 15).
  • Placebo infusion — DRUG
    2 infusions of placebo at a 2 week interval.
  • Premedications — DRUG
    Premedications prior to rituximab or placebo infusions: * IV Dexchlorpheniramine Maleate IV: 10 mg * IV Methylprednisolone: 40 mg * PO Paracetamol : 1 gram

Study Details

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).

Key Dates

Start date
Jun 29, 2023
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Patient with anti-MAG neuropathy will be included. They will randomized in placebo or Rituximab group. They will have the same premedications prior to rituximab or placebo infusions: * IV Dexchlorpheniramine Maleate IV: 10 mg * IV Methylprednisolone: 40 mg * PO Paracetamol : 1 gram
  • Active Comparator: Rituximab
    Patient with anti-MAG neuropathy will be included. They will randomized in placebo or Rituximab group. They will have the same premedications prior to rituximab or placebo infusions: * IV Dexchlorpheniramine Maleate IV: 10 mg * IV Methylprednisolone: 40 mg * PO Paracetamol : 1 gram

Primary Outcome Measure

I-RODS score [ Time Frame: Baseline and 12 months ]

Central Contacts