Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
BIOMARK
Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
1 other identifier
observational
44
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2014
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2014
CompletedFirst Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2021
CompletedFebruary 15, 2023
February 1, 2023
7.6 years
December 10, 2015
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood-levels of biomarkers of Intravenous immunoglobulin response
8 weeks
Study Arms (2)
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
control
healthy subjects
Interventions
Eligibility Criteria
patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects
You may qualify if:
- chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
- first line of treatment
- treatment with intravenous immunoglobulin required
- healthy subjects matched for age and gender
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CHU Bordeaux, service de Neurologie
Bordeaux, Aquitaine, 33000, France
CHU Nantes, Laboratoire d'explorations fonctionnelles
Nantes, Loire Atlantique, 44000, France
CHU de Brest
Brest, 29609, France
CHU de CAEN
Caen, 14000, France
Service de Neurologie Hopital du Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270, France
CHRU Lille
Lille, 59000, France
Service de Neurologie, CHU Limoges,
Limoges, 87042, France
Hôpital Neurologique HCL, Lyon-Bron
Lyon, 69677, France
CHU de NIMES
Nîmes, 30900, France
Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière
Paris, 75010, France
Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019, France
Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye
Poissy, 78303, France
CHU de Poitiers
Poitiers, 86021, France
CHU de ROUEN
Rouen, 76000, France
Centre Hospitalier de Saint-Denis
Saint-Denis, 93205, France
Service de Neurologie CHU St Etienne
Saint-Etienne, 42055, France
Service de Neurologie, CHU de Strasbourg
Strasbourg, 67098, France
CHU Henri Mondor
Créteil, Île-de-France Region, 94000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 14, 2015
Study Start
April 16, 2014
Primary Completion
November 15, 2021
Study Completion
November 15, 2021
Last Updated
February 15, 2023
Record last verified: 2023-02