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

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ClinicalTrials.gov Identifier: NCT02629796
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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

Condition or disease Intervention/treatment
CIDP Other: CIDP treated (IVIG)

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
Actual Study Start Date : April 2014
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : June 2022


Group/Cohort Intervention/treatment
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)
usual treatment with intravenous immunoglobulin

control
healthy subjects



Primary Outcome Measures :
  1. blood-levels of biomarkers of Intravenous immunoglobulin response [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


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): NCT02629796


Contacts
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Contact: Antoine GUEGUEN, MD agueguen@fo-rothschild.fr

Locations
Show Show 18 study locations
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02629796    
Other Study ID Numbers: AGN_2013-9
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Biomarker
CIDP
IVIG
treatment response
Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases