Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 24 for:    nerve | CIDP

Transcriptome Analysis of the Peripheral Blood in CIDP (PHARMACOPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404298
Recruitment Status : Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Autoimmune Diseases Clarkson Syndrome Muscular Autoimmune Disorders Drug: IVIg Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells
Actual Study Start Date : February 2015
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: IVIg Drug: IVIg



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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+

  2. IgG [ Time Frame: 3 weeks ]
    To measure IgG in a peripheral blood sample at T1 and T2 time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404298


Locations
Layout table for location information
France
Grooupe Hospitalier Pitié Salpetrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Karine Viala, MD Assistance Publique - Hôpitaux de Paris

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02404298     History of Changes
Other Study ID Numbers: P111122
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Transcriptome analysis
peripheral blood
chronic inflammatory demyelinating polyradiculoneuropathy
auto immune diseases
IVIg
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases
Immune System Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs