Transcriptome Analysis of the Peripheral Blood in CIDP (PHARMACOPID)

June 1, 2018 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Grooupe Hospitalier Pitié Salpetrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IVIg
Drug: IVIg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression profile
Time Frame: 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)
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression profile in each lymphocytary sub-group
Time Frame: 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+
3 weeks
IgG
Time Frame: 3 weeks
To measure IgG in a peripheral blood sample at T1 and T2 time
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Karine Viala, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (ESTIMATE)

March 31, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P111122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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