Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study

Last updated: January 16, 2026
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Clinical examination and patients' questionnaires regarding activity and participation (preliminary Immunogloblin M (IgM)-Rasch-built overall Disability Scale (RODS), and finalized IgM-RODS)

Clinical Study ID

NCT03918421
69HCL19_0217
2019-A00884-53
  • Ages > 18
  • All Genders

Study Summary

There is no international consensus regarding how to assess and treat patients with immunoglobulin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The purpose of the IMAGiNe study-Lyon/Bicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study.

The main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale (RODS) that should fulfill all modern clinimetric requirements, including cross-cultural validity. The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht, both in the Netherlands.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • fulfilling the international criteria for the diagnosis Immunogloblin M (IgM)monoclonal gammopathy, with anti-myelin-associated-glycoprotein (MAG) antibodies,and peripheral neuropathy.

  • age of 18 years or older followed in neuromuscular department of Lyon;

  • informed consent given by the participant

Exclusion

Exclusion Criteria:

  • concomitant diseases possibly interfering with peripheral nerve and function, aswell as physical functioning, such as diabetes, renal insufficiency, (prior)treatment with chemotherapy for diseases other than their Immunogloblin M (IgM)monoclonal gammopathy associated peripheral neuropathy, history of hereditaryneuropathy, vitamin deficiency, connective tissue disorder, hepatitis B and C andhuman immunodeficiency virus (HIV) infection, alcohol abuse (more than 5International Units(IU)/day);

  • an active malignancy with poor prognosis, undergoing treatment aside from monoclonalgammopathy associated peripheral neuropathy;

  • pregnant;

  • the use of any medication that may cause peripheral nerve function

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Clinical examination and patients' questionnaires regarding activity and participation (preliminary Immunogloblin M (IgM)-Rasch-built overall Disability Scale (RODS), and finalized IgM-RODS)
Phase:
Study Start date:
June 23, 2020
Estimated Completion Date:
June 23, 2030

Connect with a study center

  • Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302

    Bron, 69500
    France

    Site Not Available

  • Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302

    Bron 3029931, 69500
    France

    Active - Recruiting

  • Centre de référence NNERf

    Le Kremlin-Bicêtre, 94275
    France

    Site Not Available

  • Centre de référence NNERf

    Le Kremlin-Bicêtre 3003737, 94275
    France

    Active - Recruiting

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