Clinical Trial: Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
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
Detailed Summary:
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Current Primary Outcome: blood-levels of biomarkers of Intravenous immunoglobulin response [ Time Frame: 8 weeks ]
Original Primary Outcome: identify predictive biomarkers of identify predictive biomarkers of Intravenous immunoglobulin response in chronic inflammatory demyelinating polyradiculoneuropathy [ Time Frame: 8 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: assess the predictive value of biomarkers [ Time Frame: 8 weeks ]
Information By: Fondation Ophtalmologique Adolphe de Rothschild
Dates:
Date Received: December 10, 2015
Date Started: April 2014
Date Completion: December 2018
Last Updated: February 3, 2017
Last Verified: May 2016
