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Transcriptome Analysis of the Peripheral Blood in CIDP (PHARMACOPID)

Primary Purpose

Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Autoimmune Diseases, Clarkson Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IVIg
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy focused on measuring Transcriptome analysis, peripheral blood, chronic inflammatory demyelinating polyradiculoneuropathy, auto immune diseases, IVIg

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion criteria :

  • pregnancy
  • breastfeeding

Sites / Locations

  • Grooupe Hospitalier Pitié Salpetrière

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IVIg

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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+
IgG
To measure IgG in a peripheral blood sample at T1 and T2 time

Full Information

First Posted
February 6, 2015
Last Updated
June 1, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02404298
Brief Title
Transcriptome Analysis of the Peripheral Blood in CIDP
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Autoimmune Diseases, Clarkson Syndrome, Muscular Autoimmune Disorders
Keywords
Transcriptome analysis, peripheral blood, chronic inflammatory demyelinating polyradiculoneuropathy, auto immune diseases, IVIg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVIg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IVIg
Primary Outcome Measure Information:
Title
Gene expression profile
Description
Change of the gene expression profile of a peripheral blood sample collected. just before IVIg administration (T1), and 3 weeks after IVIg treatment (T2)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Gene expression profile in each lymphocytary sub-group
Description
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+
Time Frame
3 weeks
Title
IgG
Description
To measure IgG in a peripheral blood sample at T1 and T2 time
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine Viala, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grooupe Hospitalier Pitié Salpetrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Learn more about this trial

Transcriptome Analysis of the Peripheral Blood in CIDP

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