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

February 14, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHU de Brest
      • Caen, France, 14000
        • CHU de Caen
      • Le Kremlin-Bicêtre, France, 94270
        • Service de Neurologie Hopital du Kremlin Bicêtre
      • Lille, France, 59000
        • CHRU Lille
      • Limoges, France, 87042
        • Service de Neurologie, CHU Limoges,
      • Lyon, France, 69677
        • Hôpital Neurologique HCL, Lyon-Bron
      • Nimes, France, 30900
        • CHU de Nimes
      • Paris, France, 75010
        • Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière
      • Paris, France, 75019
        • Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
      • Poissy, France, 78303
        • Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Rouen, France, 76000
        • CHU de Rouen
      • Saint-Denis, France, 93205
        • Centre Hospitalier de Saint-Denis
      • Saint-Etienne, France, 42055
        • Service de Neurologie CHU St Etienne
      • Strasbourg, France, 67098
        • Service de Neurologie, CHU de Strasbourg
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • CHU Bordeaux, service de Neurologie
    • Ile De France
      • Créteil, Ile De France, France, 94000
        • CHU Henri Mondor
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44000
        • CHU Nantes, Laboratoire d'explorations fonctionnelles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
healthy subjects
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
Other: CIDP treated (IVIG)
usual treatment with intravenous immunoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood-levels of biomarkers of Intravenous immunoglobulin response
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2014

Primary Completion (Actual)

November 15, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGN_2013-9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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