PHARMACOPID: Transcriptome Analysis of the Peripheral Blood in CIDP

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT02404298

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Autoimmune Diseases Clarkson Syndrome Muscular Autoimmune Disorders	Drug: IVIg	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IVIg	Drug: IVIg

Arm

Intervention/Treatment

Experimental: IVIg

Drug: IVIg

Outcome Measures

Primary Outcome Measures

Gene expression profile [3 weeks]
Change of the gene expression profile of a peripheral blood sample collected. just before IVIg administration (T1), and 3 weeks after IVIg treatment (T2)

Secondary Outcome Measures

Gene expression profile in each lymphocytary sub-group [3 weeks]
Change of the gene expression profile of a peripheral blood sample collected. just before IVIg administration (T1), and 3 weeks after IVIg treatment (T2), in each lymphocytary sub-group : CD3+CD4+, CD3+CD8+, CD4+FoxP3+, CD4+CD25+
IgG [3 weeks]
To measure IgG in a peripheral blood sample at T1 and T2 time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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