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
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
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
NCT ID
NCT02404298
First Posted
February 6, 2015
Last Updated
June 1, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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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