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

CIDP Clinical Trial

— BIOMARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629796
• Other study ID #: AGN_2013-9
• Status: Completed
• Start date: April 16, 2014
• Est. completion date: November 15, 2021

Study information

• Verified date: February 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CIDP
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Other:
• CIDP treated (IVIG)
usual treatment with intravenous immunoglobulin

Locations

Country	Name	City	State
France	CHU Bordeaux, service de Neurologie	Bordeaux	Aquitaine
France	CHU de Brest	Brest
France	CHU de CAEN	Caen
France	CHU Henri Mondor	Créteil	Ile De France
France	Service de Neurologie Hopital du Kremlin Bicêtre	Le Kremlin-Bicêtre
France	CHRU Lille	Lille
France	Service de Neurologie, CHU Limoges,	Limoges
France	Hôpital Neurologique HCL, Lyon-Bron	Lyon
France	CHU Nantes, Laboratoire d'explorations fonctionnelles	Nantes	Loire Atlantique
France	CHU de NIMES	Nimes
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood-levels of biomarkers of Intravenous immunoglobulin response		8 weeks