ClinicalTrials.gg
CompletedNCT02629796BIOMARKUpdated Feb 15, 2023

Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

An observational study in CIDP, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 18 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
44
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.

Started
2014
with 1 other
Observational
9 of 38
2 open now
Registered
10th of 38
by date

Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, this one is one of 2 that started in 2014, is one of 9 observational ones, and was the 10th 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 · healthy volunteers too.

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02

Study summary

This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6 and 12 months after the first IVIG course. Responder/No responder status will be defined at 3 month and confirmed at 12 months. Blood samples will be collected before the IVIG course at baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample will be collected to assess early changes of transcriptome. The CIDP diagnosis and responder/no responder status will be confirmed by an independent committee. The transcriptome of the patients will be individually analyzed and compared regarding Responder/Non responder status to a control groups of 20 healthy subjects

03

Conditions studied

  • CIDP

Keywords

  • Biomarker
  • CIDP
  • IVIG
  • treatment response
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects

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

  • chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
  • of treatment
  • treatment with intravenous immunoglobulin required
  • healthy subjects matched for age and gender

Exclusion criteria

Exclusion Criteria:

For CIDP patients

  • uncontrolled diabetes, monoclonal spike with anti-ganglioside activity, anti myelin-associated glycoprotein antibodies, infection, infection, infection, connective tissue disease, hemopathy, evolutive disease)

For healthy subjects:

any chronic or disease

For all subjets viral or bacterial infection in the last 30 days chemotherapy in the last 5 years therapy

Terms in these criteria, in plain language(6)

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.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • CIDP treated (IVIG)

    patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) according to European criteria, treated with IVIG (intravenous immunoglobulin as a first line of treatment) as a usual treatment

    Other: CIDP treated (IVIG)

  • control

    healthy subjects

Interventions

  • OtherCIDP treated (IVIG)

    usual treatment with intravenous immunoglobulin

06

What researchers measure

Primary outcomes

  1. blood-levels of biomarkers of Intravenous immunoglobulin response

    Time frame: 8 weeks

07

Study locations

18 sites
  • CHU Bordeaux, service de Neurologie
    Bordeaux, Aquitaine 33000, France
  • CHU Henri Mondor
    Créteil, Ile De France 94000, France
  • CHU Nantes, Laboratoire d'explorations fonctionnelles
    Nantes, Loire Atlantique 44000, France
  • CHU de Brest
    Brest, 29609, France
  • CHU de CAEN
    Caen, 14000, France
  • Service de Neurologie Hopital du Kremlin Bicêtre
    Le Kremlin-Bicêtre, 94270, France
  • CHRU Lille
    Lille, 59000, France
  • Service de Neurologie, CHU Limoges,
    Limoges, 87042, France
  • Hôpital Neurologique HCL, Lyon-Bron
    Lyon, 69677, France
  • CHU de NIMES
    Nimes, 30900, France
  • Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière
    Paris, 75010, France
  • Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
    Paris, 75019, France
  • Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye
    Poissy, 78303, France
  • CHU de Poitiers
    Poitiers, 86021, France
  • CHU de ROUEN
    Rouen, 76000, France
  • Centre Hospitalier de Saint-Denis
    Saint-Denis, 93205, France
  • Service de Neurologie CHU St Etienne
    Saint-Etienne, 42055, France
  • Service de Neurologie, CHU de Strasbourg
    Strasbourg, 67098, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2014 to primary completion in Nov 2021, 90 months.

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

Registered
Dec 10, 2015
First posted
Dec 14, 2015
StartActual
Apr 16, 2014
Primary completionActual
Nov 15, 2021
CompletionActual
Nov 15, 2021
Last update
Feb 15, 2023
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 Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02629796
Responsible party
Sponsor
First posted
Dec 14, 2015
Start date
Apr 16, 2014
Primary completion
Nov 15, 2021
Completion
Nov 15, 2021
Last update
Feb 15, 2023
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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