Transcriptome Analysis of the Peripheral Blood in CIDP

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Brief Title

Transcriptome Analysis of the Peripheral Blood in CIDP

Official Title

Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells

Brief Summary

      Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated
      disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy
      for CIDP. The investigators used a transcriptomic approach to compare the gene expression
      profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and
      after IVIg treatment, in order to identify their mechanism of action in this condition, to
      lead to a better understanding of CIDP pathophysiology, and potentially determine factors
      associated with the response to the treatment.
    

Detailed Description

      We study the change of the:

        -  gene profile on transcriptome analysis of peripheral blood

        -  T cell repertory

        -  igG dosage

        -  immunological profile

      Before IVIG (T1 time) and and 3 weeks after IVIg treatment (T2 time). On a population of
      patients having: CIDP, autoimmune muscular disease, Clarkson syndrome, or autoimmune
      diseases.

      We also search for polymorphism of FCgammareceptor, TKPC et CASP3 genes in CIDP patients
    


Study Type

Interventional


Primary Outcome

Gene expression profile

Secondary Outcome

 Gene expression profile in each lymphocytary sub-group

Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention

IVIg

Study Arms / Comparison Groups

 IVIg
Description:  

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

Drug

Estimated Enrollment

50

Start Date

February 2015

Completion Date

September 2018

Primary Completion Date

January 2018

Eligibility Criteria

        Inclusion criteria :

          -  Age ≥ 18 years old

          -  Obtained informed consent

          -  Patient having a definite or probable CIDP according to EFNS/PNS criteria or atypical
             CIDP corresponding to patients having the EFNS/PNS clinical criteria and at least two
             EFNS/PNS supportive criteria

          -  Or

          -  Patient having a muscular autoimmune disease, or a Clarkson syndrome or other
             autoimmune disease

          -  Currently treated by IVIG

        Exclusion criteria :

          -  pregnancy

          -  breastfeeding
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karine Viala, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02404298

Organization ID

P111122


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Karine Viala, MD, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

May 2018