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

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 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

NCT ID

NCT02629796

Organization ID

AGN_2013-9

Responsible Party

Sponsor

Study Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study Sponsor

, , 

Verification Date

December 2021