Transcriptome Analysis of the Peripheral Blood in CIDP

Autoimmune Diseases Clinical Trial

— PHARMACOPID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02404298
• Other study ID #: P111122
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Clarkson Syndrome
• Muscular Autoimmune Disorders
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
• IVIg

Locations

Country	Name	City	State
France	Grooupe Hospitalier Pitié Salpetrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression profile	Change of the gene expression profile of a peripheral blood sample collected. just before IVIg administration (T1), and 3 weeks after IVIg treatment (T2)	3 weeks
Secondary	Gene expression profile in each lymphocytary sub-group	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+	3 weeks
Secondary	IgG	To measure IgG in a peripheral blood sample at T1 and T2 time	3 weeks