Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

NCT ID: NCT02629796

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-16

Study Completion Date

2021-11-15

Brief Summary

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This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6 and 12 months after the first IVIG course. Responder/No responder status will be defined at 3 month and confirmed at 12 months. Blood samples will be collected before the IVIG course at baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample will be collected to assess early changes of transcriptome. The CIDP diagnosis and responder/no responder status will be confirmed by an independent committee. The transcriptome of the patients will be individually analyzed and compared regarding Responder/Non responder status to a control groups of 20 healthy subjects

Detailed Description

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Conditions

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CIDP

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CIDP treated (IVIG)

patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) according to European criteria, treated with IVIG (intravenous immunoglobulin as a first line of treatment) as a usual treatment

CIDP treated (IVIG)

Intervention Type OTHER

usual treatment with intravenous immunoglobulin

control

healthy subjects

No interventions assigned to this group

Interventions

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CIDP treated (IVIG)

usual treatment with intravenous immunoglobulin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
* first line of treatment
* treatment with intravenous immunoglobulin required
* healthy subjects matched for age and gender

Exclusion Criteria

For CIDP patients

* uncontrolled diabetes, monoclonal spike with anti-ganglioside activity, anti myelin-associated glycoprotein antibodies, HIV infection, HBV infection, HCV infection, connective tissue disease, hemopathy, evolutive disease)

For healthy subjects:

any chronic or autoimmune disease

For all subjets viral or bacterial infection in the last 30 days chemotherapy in the last 5 years immunosuppressive therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux, service de Neurologie

Bordeaux, Aquitaine, France

Site Status

CHU Nantes, Laboratoire d'explorations fonctionnelles

Nantes, Loire Atlantique, France

Site Status

CHU de Brest

Brest, , France

Site Status

CHU de CAEN

Caen, , France

Site Status

Service de Neurologie Hopital du Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

CHRU Lille

Lille, , France

Site Status

Service de Neurologie, CHU Limoges,

Limoges, , France

Site Status

Hôpital Neurologique HCL, Lyon-Bron

Lyon, , France

Site Status

CHU de NIMES

Nîmes, , France

Site Status

Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière

Paris, , France

Site Status

Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye

Poissy, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

CHU de ROUEN

Rouen, , France

Site Status

Centre Hospitalier de Saint-Denis

Saint-Denis, , France

Site Status

Service de Neurologie CHU St Etienne

Saint-Etienne, , France

Site Status

Service de Neurologie, CHU de Strasbourg

Strasbourg, , France

Site Status

CHU Henri Mondor

Créteil, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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AGN_2013-9

Identifier Type: -

Identifier Source: org_study_id

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