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