Clinical trial NCT03918421: Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study
Official title: Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study: From Proper Assessment to Trial Needs - IMAGiNe Study-Lyon/Bicêtre
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 18 years old fulfilling the international criteria for Immunogloblin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy and peripheral neuropathy

Brief 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 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

Primary outcomes:
measure: Change in patient activity and participation according to patient questionnaires
timeFrame: 0, 6, 12, 24 and 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302
city: Le Kremlin-Bicêtre
country: France
facility: Centre de référence NNERf
Study officials:
affiliation: Hospices Civils de Lyon
name: Juliette SVAHN, MD
role: PRINCIPAL_INVESTIGATOR
References: