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

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ClinicalTrials.gov Identifier: NCT03918421
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 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.


Condition or disease Intervention/treatment
Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy Other: 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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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study: From Proper Assessment to Trial Needs - IMAGiNe Study-Lyon
Estimated Study Start Date : May 5, 2019
Estimated Primary Completion Date : May 5, 2023
Estimated Study Completion Date : May 5, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Immunogloblin M-anti myelin-associated-glycoprotein neuropathy
Patient group (25 subjects) presenting with an Immunogloblin M-anti myelin-associated-glycoprotein peripheral neuropathy
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 (patients' actual responses to scale items) accord with predictions of those responses from a mathematical model.




Primary Outcome Measures :
  1. Change in patient activity and participation according to patient questionnaires [ Time Frame: 0, 6, 12, 24 and 36 months ]
    Preliminary Immunogloblin M (IgM)-Rasch-built Overall Disability Scale (RODS), and after its construction the 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 (patients' actual responses to scale items) accord with predictions of those responses from a mathematical model.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918421


Contacts
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Contact: Juliette SVAHN, MD 4 72 11 66 08 ext 33 juliette.svahn@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Juliette SVAHN, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03918421     History of Changes
Other Study ID Numbers: 69HCL19_0217
2019-A00884-53 ( Other Identifier: ID-RCB )
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Immunoglobulins
Antibodies
polysaccharide-K
Immunoglobulin M
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents