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Status unknownNCT02404298PHARMACOPIDUpdated Jun 4, 2018

Transcriptome Analysis of the Peripheral Blood in CIDP

An interventional study of IVIg in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Autoimmune Diseases and Clarkson Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-04.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

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

Keywords

  • Transcriptome analysis
  • peripheral blood
  • chronic inflammatory demyelinating polyradiculoneuropathy
  • auto immune diseases
  • IVIg
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria :

  • pregnancy
  • breastfeeding
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    IVIg

    Drug: IVIg

Interventions

  • DrugIVIg
05

What researchers measure

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)

    Time frame: 3 weeks

Secondary outcomes

  1. 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+

    Time frame: 3 weeks

  2. IgG

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

    Time frame: 3 weeks

06

Study locations

1 site
  • Grooupe Hospitalier Pitié Salpetrière
    Paris, 75013, France
07

Registry details

Key details

Study ID
NCT02404298
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 31, 2015
Start date
Feb 2015
Primary completion
Jan 2018
Completion
Sep 2018 (estimated)
Last update
Jun 4, 2018

Study contacts

Karine Viala, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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