ClinicalTrials.gg
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this record recently (last verified May 2018), so the status shown — last known as Active, not recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France — 8 open to participants now, 10 under way, 7 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · France.

Planned enrollment
17th of 29
50 · median 82
Started
2015
with 3 others
No phase
6 of 38
none open now
Registered
8th of 38
by date
Lead sponsor
2 of 38
Assistance Publique - Hôpitaux de Paris

Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, this one is the 17th largest by planned enrollment of the 29 interventional ones that give a count, is one of 4 that started in 2015, is one of 6 with no phase, and was the 8th registered.

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Open to participants now

8 of the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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

03

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
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years old
  • Obtained
  • 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 disease, or a Clarkson syndrome or other autoimmune disease
  • Currently treated by IVIG

Exclusion criteria

Exclusion criteria :

  • pregnancy
  • breastfeeding
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

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

06

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

07

Study locations

1 site
  • Grooupe Hospitalier Pitié Salpetrière
    Paris, 75013, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2015 to primary completion in Jan 2018, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2015
First posted
Mar 31, 2015
StartActual
Feb 2015
Primary completionActual
Jan 2018
CompletionEst.
Sep 2018
Last update
Jun 4, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02404298
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 ↗

Not currently enrolling

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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Studies of the drug tested here: Immunoglobulins, Intravenous

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