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

Completed

• Conditions: CIDP
• Interventions: Other: CIDP treated (IVIG)

• Registration Number: NCT02629796
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-16
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-14
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CIDP treated (IVIG)	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

Primary Outcome Measures

Name	Time	Method
blood-levels of biomarkers of Intravenous immunoglobulin response	8 weeks

Trial Locations

Locations (18)

CHU Bordeaux, service de Neurologie; 🇫🇷 Bordeaux, Aquitaine, France

CHU Henri Mondor; 🇫🇷 Créteil, Ile De France, France

CHU Nantes, Laboratoire d'explorations fonctionnelles; 🇫🇷 Nantes, Loire Atlantique, France

CHU de Brest; 🇫🇷 Brest, France

CHU de CAEN; 🇫🇷 Caen, France

CHRU Lille; 🇫🇷 Lille, France

CHU de NIMES; 🇫🇷 Nimes, France

Service de Neurologie Hopital du Kremlin Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Service de Neurologie, CHU Limoges,; 🇫🇷 Limoges, France

Hôpital Neurologique HCL, Lyon-Bron; 🇫🇷 Lyon, France

Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France

Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière; 🇫🇷 Paris, France

Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye; 🇫🇷 Poissy, France

CHU de Poitiers; 🇫🇷 Poitiers, France

CHU de ROUEN; 🇫🇷 Rouen, France

Centre Hospitalier de Saint-Denis; 🇫🇷 Saint-Denis, France

Service de Neurologie CHU St Etienne; 🇫🇷 Saint-Etienne, France

Service de Neurologie, CHU de Strasbourg; 🇫🇷 Strasbourg, France