CIDPBIOMARKNCT02629796
Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
An observational study of CIDP, run by Fondation Ophtalmologique Adolphe de Rothschild at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CIDP
- What is being tested?
- CIDP treated (IVIG)
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 18 sitesFrance
- Study dates
- 16 Apr 2014to 15 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects
Who may be able to join
- chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
- first line of treatment
- treatment with intravenous immunoglobulin required
- healthy subjects matched for age and gender
Who cannot join
- For CIDP patients
- uncontrolled diabetes, monoclonal spike with anti-ganglioside activity, anti myelin-associated glycoprotein antibodies, HIV infection, HBV infection, HCV infection, connective tissue disease, hemopathy, evolutive disease)
- For healthy subjects:
- any chronic or autoimmune disease
- For all subjets viral or bacterial infection in the last 30 days chemotherapy in the last 5 years immunosuppressive therapy
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Bordeaux, service de Neurologie
Bordeaux, Aquitaine, 33000
CHU de Brest
Brest, 29609
CHU de CAEN
Caen, 14000
CHU Henri Mondor
Créteil, Île-de-France Region, 94000
Service de Neurologie Hopital du Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
CHRU Lille
Lille, 59000
Service de Neurologie, CHU Limoges,
Limoges, 87042
Hôpital Neurologique HCL, Lyon-Bron
Lyon, 69677
CHU Nantes, Laboratoire d'explorations fonctionnelles
Nantes, Loire Atlantique, 44000
CHU de NIMES
Nîmes, 30900
Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière
Paris, 75010
Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye
Poissy, 78303
CHU de Poitiers
Poitiers, 86021
CHU de ROUEN
Rouen, 76000
Centre Hospitalier de Saint-Denis
Saint-Denis, 93205
Service de Neurologie CHU St Etienne
Saint-Etienne, 42055
Service de Neurologie, CHU de Strasbourg
Strasbourg, 67098
About this study
Official title: Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
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
- Conditions
- CIDP
- Being tested
- CIDP treated (IVIG)
- Keywords
- Biomarker, CIDP, IVIG, treatment response
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIDP treated (IVIG)Other
usual treatment with intravenous immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: CIDP treated (IVIG) | |
| control | healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood-levels of biomarkers of Intravenous immunoglobulin response
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study start16 Apr 2014
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIDPStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629796
- Sponsor's protocol ID
- AGN_2013-9
- Acronym
- BIOMARK
- Status last verified
- Feb 2023
- First submitted
- 10 Dec 2015
- Last updated
- 15 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
- ClinicalTrials.gov ID
- NCT02629796
- Acronym / sponsor ID
- BIOMARK / AGN_2013-9
- Conditions
- CIDP
- Keywords
- Biomarker, CIDP, IVIG, treatment response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 16 Apr 2014 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIDP treated (IVIG) | – | Other: 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 |
| control | – | –healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects
Key inclusion criteria (4 listed)
- chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
- first line of treatment
- treatment with intravenous immunoglobulin required
- healthy subjects matched for age and gender
Key exclusion criteria (5 listed)
- For CIDP patients
- uncontrolled diabetes, monoclonal spike with anti-ganglioside activity, anti myelin-associated glycoprotein antibodies, HIV infection, HBV infection, HCV infection, connective tissue disease, hemopathy, evolutive disease)
- any chronic or autoimmune disease
- For all subjets viral or bacterial infection in the last 30 days chemotherapy in the last 5 years immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIDP treated (IVIG)usual treatment with intravenous immunoglobulin | Other | CIDP treated (IVIG) |
Primary outcome
blood-levels of biomarkers of Intravenous immunoglobulin response
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Related trials for CIDP
RecruitingObservational study
Studying Nerve Function and Structure in Charcot-Marie-Tooth Disease, Anti-MAG Neuropathy and CIDP
Charcot-Marie-Tooth, CMT1A
Active, not recruitingPhase 2
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
RecruitingPhase 2
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
RecruitingObservational study
Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CIDP, run by Fondation Ophtalmologique Adolphe de Rothschild at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood-levels of biomarkers of Intravenous immunoglobulin response (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.