NCT03918421 Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study
| NCT ID | NCT03918421 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2020-06-23 |
| Primary Completion | 2030-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2020-06-23 with a primary completion date of 2030-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Juliette SVAHN, MD
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT03918421 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03918421 currently recruiting?
Yes, NCT03918421 is actively recruiting participants. Contact the research team at juliette.svahn@chu-lyon.fr for enrollment information.
Where is the NCT03918421 trial being conducted?
This trial is being conducted at Bron, France, Le Kremlin-Bicêtre, France.
Who is sponsoring the NCT03918421 clinical trial?
NCT03918421 is sponsored by Hospices Civils de Lyon. The principal investigator is Juliette SVAHN, MD at Hospices Civils de Lyon. The trial plans to enroll 45 participants.