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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 14, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date December 10, 2015
First Posted Date December 14, 2015
Last Update Posted Date June 14, 2019
Actual Study Start Date April 2014
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2015)
blood-levels of biomarkers of Intravenous immunoglobulin response [ Time Frame: 8 weeks ]
Original Primary Outcome Measures
 (submitted: December 11, 2015)
identify predictive biomarkers of identify predictive biomarkers of Intravenous immunoglobulin response in chronic inflammatory demyelinating polyradiculoneuropathy [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT02629796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: December 11, 2015)
assess the predictive value of biomarkers [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Official Title Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects
Condition CIDP
Intervention Other: CIDP treated (IVIG)
usual treatment with intravenous immunoglobulin
Study Groups/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
    Intervention: Other: CIDP treated (IVIG)
  • control
    healthy subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 11, 2015)
45
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Antoine GUEGUEN, MD agueguen@fo-rothschild.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02629796
Other Study ID Numbers AGN_2013-9
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date June 2019