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Recruiting NCT03918421

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

— Observational Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical examination and patients' questionnaires regarding activity and participation (preliminary Immunogloblin M (IgM)-Rasch-built overall Disability Scale (RODS), and finalized IgM-RODS).
Who it may be relevant to
Registry conditions: Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study: From Proper Assessment to Trial Needs - IMAGiNe Study-Lyon/Bicêtre

Overview

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.

Interventions

  • Other Clinical examination and patients' questionnaires regarding activity and participation (preliminary Immunogloblin M (IgM)-Rasch-built overall Disability Scale (RODS), and finalized IgM-RODS)
    Rasch-built overall Disability Scale (RODS) is a disease-specific, patient-based, linearly weighted scale that captures activity and social participation limitations to detect activity limitations in patients with Immunogloblin M (IgM) anti-myelin-associated-glycoprotein peripheral neuropathy. For this study, the preliminary RODS is a 146 item patient-reported outcome instrument that assesses activity and social participation limitation. Rasch Measurement Methods examine the extent observed data

Primary outcome measures

  • Change in patient activity and participation according to patient questionnaires [Time frame: 0, 6, 12, 24 and 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302 — Bron
  • Centre de référence NNERf — Le Kremlin-Bicêtre

Identifiers

NCT: NCT03918421 · 69HCL19_0217 · 2019-A00884-53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗