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

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ClinicalTrials.gov Identifier: NCT02629796
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
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

Condition or disease Intervention/treatment
CIDP Other: CIDP treated (IVIG)

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
Actual Study Start Date : April 2014
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : June 2022


Group/Cohort Intervention/treatment
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

control
healthy subjects



Primary Outcome Measures :
  1. blood-levels of biomarkers of Intravenous immunoglobulin response [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects
Criteria

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


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): NCT02629796


Contacts
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Contact: Antoine GUEGUEN, MD agueguen@fo-rothschild.fr

Locations
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France
CHU Bordeaux, service de Neurologie Recruiting
Bordeaux, Aquitaine, France, 33000
Contact: Guilhem SOLE, MD       guilhem.sole@chu-bordeaux.fr   
CHU Henri Mondor Recruiting
Créteil, Ile De France, France, 94000
Contact: Alain CREANGE, MD       alain.creange@aphp.fr   
CHU Nantes, Laboratoire d'explorations fonctionnelles Recruiting
Nantes, Loire Atlantique, France, 44000
Contact: Armelle MAGOT, MD       armelle.magot@chu-nantes.fr   
CHU de Brest Not yet recruiting
Brest, France, 29609
Contact: Steeve GENESTET, MD       steeve.genestet@chu-brest.fr   
CHU de CAEN Recruiting
Caen, France, 14000
Contact: Mathilde LEFILLIATRE, MD       lefilliatre-m@chu-caen.fr   
Service de Neurologie Hopital du Kremlin Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Andoni ECHANIZ-LAGUNA         
CHRU Lille Recruiting
Lille, France, 59000
Contact: Celine TARD, MD       celinetardpro@gmail.com   
Service de Neurologie, CHU Limoges, Recruiting
Limoges, France, 87042
Contact: Laurent Magy, MD       laurent.magy@unilim.fr   
Hôpital Neurologique HCL, Lyon-Bron Recruiting
Lyon, France, 69677
Contact: Christophe VIAL, MD       christophe.vial@chu-lyon.fr   
CHU de NIMES Recruiting
Nimes, France, 30900
Contact: Astrid COLORBE, MD       astrid.colorbe@chu-nimes.fr   
Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Pierre LOZERON, MD       pierre.lozeron@lrb.aphp.fr   
Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Antoine Gueguen, MD    +33143086755    agueguen@fo-rothschild.fr   
Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye Not yet recruiting
Poissy, France, 78303
Contact: Olivier HEINZLEF, MD       oheinzlef@chi-poissy-st-germain.fr   
CHU de Poitiers Recruiting
Poitiers, France, 86021
Contact: Adrien JULIAN         
CHU de ROUEN Recruiting
Rouen, France, 76000
Contact: Anne-Laure MILLET, MD       anne-laure.millet@chu-rouen.fr   
Centre Hospitalier de Saint-Denis Recruiting
Saint-Denis, France, 93205
Contact: Anne LAZAR, MD       anne.lazar@ch-stdenis.fr   
Service de Neurologie CHU St Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Jean-Philippe Camdessanche, MD    +33477127805    j.philippe.camdessanche@chu-st-etienne.fr   
Service de Neurologie, CHU de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Jean-Baptiste CHANSON         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02629796     History of Changes
Other Study ID Numbers: AGN_2013-9
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Biomarker
CIDP
IVIG
treatment response

Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs