A Phase 3 interventional study of Rituximab infusion and Placebo infusion in Anti-MAG Neuropathy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 3, Interventional, and Treatment
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).
However these trials have included unselected anti-MAG patients and methodological issues have been raised.
In COFRAMAG study, the largest cohort worldwide of anti-MAG patients, predictors of clinical response to rituximab were identified through analysis of 92 treated patients: shorter disease duration and anti-MAG titre above 10000 BTU. Thus this study will focus on rituximab efficacy in a subset of patients with disease duration of less than 2 years and anti-MAG titre above 10000 Buhlmann Titer Units (BTU). The investigators selected Inflammatory Rasch-built Overall Disability Scale (I-RODS) as primary outcome measure because its responsiveness was proven higher than INCAT/ Overall Neuropathy Limitation Score (ONLS) scales to detect clinical meaningful changes in newly treated patients with inflammatory neuropathies.
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Placebo infusion · Drug: Premedications
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
Drug: Rituximab infusion · Drug: Premedications
2 infusions of 1 gram of rituximab at a 2 week interval (day 1 followed by day 15).
Also known as: Mabthera
2 infusions of placebo at a 2 week interval.
Also known as: Sodium chloride (NaCl)
Premedications prior to rituximab or placebo infusions: * IV Dexchlorpheniramine Maleate IV: 10 mg * IV Methylprednisolone: 40 mg * PO Paracetamol : 1 gram
I-RODS score
Clinical response defined as a 4 points (or more) change of I-RODS between baseline and 12 months. I-RODS is a 24-item patient-reported outcome measure which maximum score is 48. It is a linearly weighted scale that specifically captures activity and social participation limitations in patients with inflammatory neuropathies, including Monoclonal Gammopathy of Unknown Significance (MGUS) related polyneuropathies.
Time frame: Baseline and 12 months
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
The INCAT (Inflammatory Neuropathy Cause and Treatment) disability score is a measure of activity limitation with minimum score at 0 and maximum at 10.
Time frame: Months: 0, 6, 12
Six minute walk test
Six minute walk test will be realized.
Time frame: Months : 0, 6, 12
Timed 25- foot walk (FW) test
The T25-FW is a quantitative test of mobility and performance of leg function based on a timed outward journey of 25 steps, and a timed return journey of 25 steps. The score for the T25-FW is the average of the two completed trials
Time frame: Months : 0, 6, 12
9 hole peg test
The nine hole peg test is a standardized, quantitative assessment used to measure finger dexterity. Scores are based on the time taken to complete the test activity, recorded in seconds
Time frame: Months : 0, 6, 12
ElectroNeuroMyography (ENMG)
An ENMG will be realized.
Time frame: Months : 0, 6, 12
ENMG sensory sum score
ENMG sensory sum score will be realized.
Time frame: Months : 0, 6, 12
Score Motor unit number index (MUNIX)
Score MUNIX will be realised.
Time frame: Months : 0, 6, 12
Incidence of Treatment-Emergent Adverse Events of Rituximab
Consideration of adverse effects of Rituximab
Time frame: Months : 0, 6, 12
the anti-MAG antibody titre.
To study the correlation between the clinical response and the evolution of the anti-MAG antibody titre.
Time frame: Months : 0, 6, 12
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire de Saint Etienne