Brief Title
Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Official Title
Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
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
Study Type
Observational
Primary Outcome
blood-levels of biomarkers of Intravenous immunoglobulin response
Condition
CIDP
Intervention
CIDP treated (IVIG)
Study Arms / Comparison Groups
CIDP treated (IVIG)
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
44
Start Date
April 2014
Completion Date
June 2022
Primary Completion Date
October 2021
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02629796
Organization ID
AGN_2013-9
Responsible Party
Sponsor
Study Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor
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Verification Date
December 2021