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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302
RECRUITING
Bron
Centre de référence NNERf
RECRUITING
Le Kremlin-bicêtre
Contact Information
Primary
Juliette SVAHN, MD
juliette.svahn@chu-lyon.fr
4 72 11 66 08
Time Frame
Start Date: 2020-06-23
Estimated Completion Date: 2030-06-23
Participants
Target number of participants: 45
Treatments
Immunogloblin M-anti myelin-associated-glycoprotein neuropathy
Patient group (25 subjects) presenting with an Immunogloblin M-anti myelin-associated-glycoprotein peripheral neuropathy
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov