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

  • STATUS
    Recruiting
  • End date
    Jun 14, 2022
  • participants needed
    45
  • sponsor
    Fondation Ophtalmologique Adolphe de Rothschild
Updated on 14 June 2021
immunoglobulins
igiv
immune globulin
polyradiculoneuropathy

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, nave 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

Details
Condition Chronic inflammatory demyelinating polyradiculoneuropathy, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Treatment CIDP treated (IVIG)
Clinical Study IdentifierNCT02629796
SponsorFondation Ophtalmologique Adolphe de Rothschild
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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