Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy (PREDIMAG)
26 de agosto de 2026 actualizado por: Centre Hospitalier Universitaire de Nice
A Monocentric Retrospective Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy
"Anti-myelin-associated glycoprotein (anti-MAG) neuropathy is a rare dysimmune peripheral neuropathy, most commonly associated with an IgM monoclonal gammopathy.
Its course is generally slow but may lead to significant functional disability.
Despite therapeutic advances, including rituximab, intravenous immunoglobulins (IVIg), immunochemotherapy, and more recently Bruton tyrosine kinase inhibitors (BTKi), treatment response remains highly variable between patients.
The Terminal Latency Index (TLI), an electrophysiological parameter reflecting distal demyelination, is a recognized diagnostic marker of anti-MAG neuropathy.
However, its potential role as a predictive biomarker of treatment response remains insufficiently studied.
Identifying a simple, reproducible, and readily available biomarker that could predict treatment response would be of major clinical importance for personalized patient management and optimization of therapeutic strategies.
This monocentric retrospective study will analyze clinical, biological, and electrophysiological data from patients with anti-MAG neuropathy followed at Nice University Hospital (CHU de Nice) to assess the predictive value of baseline TLI for clinical response 12 months after treatment initiation."
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Abderhmane Slioui
- Número de teléfono: +33 0492038953
- Correo electrónico: slioui.a@chu-nice.fr
Copia de seguridad de contactos de estudio
- Nombre: Mecheli Cavalli
- Número de teléfono: +33 0492035435
- Correo electrónico: puma.ar@chu-nice.fr
Ubicaciones de estudio
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Alpes Maritimes
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Nice, Alpes Maritimes, Francia, 06000
- Chu De Nice
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Contacto:
- Angela Puma
- Número de teléfono: +33 0492035435
- Correo electrónico: puma.ar@chu-nice.fr
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Contacto:
- Abderhmane de Nice
- Número de teléfono: +33 0492038953
- Correo electrónico: slioui.a@chu-nice.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
"Adult patients with documented anti-MAG activity-associated neuropathy, followed at the Reference Center for Rare Diseases of the Peripheral Nervous System at Nice University Hospital (CHU de Nice) between January 2005 and July 2025.
Planned number of participants: 100 patients."
Descripción
Inclusion Criteria:
- Documented anti-MAG IgM polyneuropathy: positive anti-MAG antibodies, associated with an IgM monoclonal gammopathy, and a compatible clinical phenotype.
- Complete and interpretable baseline ENMG assessment: an initial electroneuromyography (ENMG) examination allowing reliable calculation of the TLI in at least two motor nerves among the right median, ulnar, and common fibular nerves.
- The examination must include the distal motor latency, proximal motor conduction velocity, and compound muscle action potential (CMAP).
- Treatment with at least one established therapeutic strategy: treatment initiated at the center, including intravenous immunoglobulins (IVIg), rituximab, immunochemotherapy, Bruton tyrosine kinase inhibitors (BTKi), and/or symptomatic treatment.
- Available functional clinical assessment: a documented INCAT disability score at two predefined time points: baseline (before treatment initiation) and 12 months (±2 months) after treatment initiation.
- Consent to participate in the study.
Exclusion Criteria:
- Peripheral neuropathy associated with an IgM monoclonal gammopathy, with strictly negative anti-MAG antibody testing or no available anti-MAG antibody measurement.
- Incomplete or uninterpretable ENMG data preventing accurate calculation of the TLI for the nerves of interest (median and ulnar nerves).
- Absence of a formally documented INCAT score at baseline or within the 12-month assessment window.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Anti-myelin-associated glycoprotein (anti-MAG) neuropathy
This monocentric retrospective observational study will include 100 patients with anti-myelin-associated glycoprotein (anti-MAG) neuropathy followed at Nice University Hospital (CHU de Nice).
No additional intervention or modification of routine clinical care will be performed.
Clinical, biological, therapeutic, and electrophysiological data will be retrospectively collected from medical records and available archives.
Routinely performed electroneuromyography (ENMG) data will be analyzed, with particular emphasis on the Terminal Latency Index (TLI), calculated from available electrophysiological parameters according to the standard formula.
The predictive value of baseline TLI for clinical response to treatment at 12 months will be assessed.
Treatments received as part of routine care, including rituximab, IVIg, immunochemotherapy, and Bruton tyrosine kinase inhibitors (BTKi), will be recorded.
No treatment will be assigned or modified by the study.
Data will be pseudonymized and ent
|
This monocentric retrospective observational study will include 100 patients with anti-myelin-associated glycoprotein (anti-MAG) neuropathy followed at Nice University Hospital (CHU de Nice).
No additional intervention or modification of routine clinical care will be performed.
Clinical, biological, therapeutic, and electrophysiological data will be retrospectively collected from medical records and available archives.
Routinely performed electroneuromyography (ENMG) data will be analyzed, with particular emphasis on the Terminal Latency Index (TLI), calculated from available electrophysiological parameters according to the standard formula.
The predictive value of baseline TLI for clinical response to treatment at 12 months will be assessed.
Treatments received as part of routine care, including rituximab, IVIg, immunochemotherapy, and Bruton tyrosine kinase inhibitors (BTKi), will be recorded.
No treatment will be assigned or modified by the study.
Data will be pseudonymized and ente
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Favorable Clinical Response at 12 Months (≥1-Point Decrease in INCAT Score)
Periodo de tiempo: 12 months after treatment initiation
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Clinical response at 12 months, defined as a reduction of at least 1 point in the INCAT disability score from baseline.
This outcome will be used to assess the predictive value of the baseline Terminal Latency Index (TLI) for treatment response in patients with anti-MAG neuropathy.
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12 months after treatment initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Predictive performance of TLI according to treatment strategy
Periodo de tiempo: 12 months after treatment initiation.
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Assessment of the predictive performance of baseline TLI for clinical response at 12 months, stratified according to the treatment strategy received.
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12 months after treatment initiation.
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Correlation between TLI, anti-MAG antibody titer, and INCAT score evolution
Periodo de tiempo: Baseline to 12 months after treatment initiation
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Assessment of the association between baseline TLI, quantitative anti-MAG antibody titer, and change in the INCAT disability score from baseline to 12 months.
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Baseline to 12 months after treatment initiation
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Optimal TLI threshold for predicting treatment response
Periodo de tiempo: Baseline to 12 months after treatment initiation
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Determination of the optimal baseline TLI threshold for predicting clinical response at 12 months using Receiver Operating Characteristic (ROC) curve analysis and the Youden index
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Baseline to 12 months after treatment initiation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mecheli Cavalli
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
31 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26Neuro05
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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