Transcriptome Analysis of the Peripheral Blood in CIDP

NCT02404298 | Unknown

• 1 other identifier: P111122
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Autoimmune Diseases; Clarkson Syndrome; Muscular Autoimmune Disorders

Keywords

Transcriptome analysis; peripheral blood; chronic inflammatory demyelinating polyradiculoneuropathy; auto immune diseases; IVIg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gene expression profile in each lymphocytary sub-group

  3 weeks

• IgG

  3 weeks

Study Arms (1)

IVIg

EXPERIMENTAL

Drug: IVIg

Interventions

IVIg DRUG

IVIg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient having a muscular autoimmune disease, or a Clarkson syndrome or other autoimmune disease
• Currently treated by IVIG

You may not qualify if:

• pregnancy
• breastfeeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Grooupe Hospitalier Pitié Salpetrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Autoimmune Diseases

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Karine Viala, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: March 31, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-05

Locations

FR (1)