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

Recruitingn/aAges 18 Years - anyAllHospices Civils de Lyon
NCT03918421 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 Criteria: * concomitant diseases possibly interfering with peripheral nerve and function, as well 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 hereditary neuropathy, vitamin deficiency, connective tissue disorder, hepatitis B and C and human immunodeficiency virus (HIV) infection, alcohol abuse (more than 5 International Units(IU)/day); * an active malignancy with poor prognosis, undergoing treatment aside from monoclonal gammopathy associated peripheral neuropathy; * pregnant; * the use of any medication that may cause peripheral nerve function
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What it tests

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

2 sites
Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302
Bron, France
Centre de référence NNERf
Le Kremlin-Bicêtre, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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