Transcriptome Analysis of the Peripheral Blood in CIDP

Not Applicable

• Conditions: Autoimmune Diseases; Clarkson Syndrome; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Muscular Autoimmune Disorders
• Interventions: Drug: IVIg

• Registration Number: NCT02404298
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Primary Completion: 2018-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-04
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IVIg	IVIg	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Grooupe Hospitalier Pitié Salpetrière; 🇫🇷 Paris, France