Biomarkers in Idiopathic Juvenile Arthritis
Primary Purpose
Idiopathic Juvenile Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample for identifying biomarkers
Sponsored by
About this trial
This is an interventional diagnostic trial for Idiopathic Juvenile Arthritis
Eligibility Criteria
Inclusion Criteria for experimental group :
- child age from 2 to 16 years
- Oligoarticular JIA with antinuclear antibodies
- with or without uveitis
Exclusion criteria for experimental group :
- immunosuppressive and biological therapy
Inclusion Criteria for control group :
- child age from 2 to 16 years
Sites / Locations
- Cardiology paediatric consultation, Arnaud de Villeneuve HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
idiopathic juvenile arthritis
control
Arm Description
blood sample
blood sample
Outcomes
Primary Outcome Measures
identification of specific autoantigen biomarkers
Identify blood sampling biomarkers of juvenile idiopathic arthritis
Secondary Outcome Measures
Full Information
NCT ID
NCT02343770
First Posted
January 7, 2015
Last Updated
September 4, 2015
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02343770
Brief Title
Biomarkers in Idiopathic Juvenile Arthritis
Official Title
Usefulness of Protoarray®Microarray for Identifying Biomarkers in Idiopathic Juvenile Arthritis Antinuclear Antibodies Positive.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular JIA with antinuclear antibodies affects about half of all children. There 's no specific markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human Protein Microarray allows rapid and efficient detection of protein interaction using a suitable protein or small molecule probe. The investigators hope so detect novel potential autoantigen biomarkers specific in JIA.
Detailed Description
We select 10 patients with inclusion criteria and 10 controls. We analyse their blood sample (5ml). The ProtoArray® Microarray allows to detect novel protein-protein interactions, to rapidly perform serum profiling using a sensitive method to detect potential autoantigen biomarkers. The ProtoArray® Human Protein Microarray is a high-density protein microarray containing thousands of purified human proteins for protein interaction screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Juvenile Arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
idiopathic juvenile arthritis
Arm Type
Experimental
Arm Description
blood sample
Arm Title
control
Arm Type
Other
Arm Description
blood sample
Intervention Type
Other
Intervention Name(s)
blood sample for identifying biomarkers
Primary Outcome Measure Information:
Title
identification of specific autoantigen biomarkers
Description
Identify blood sampling biomarkers of juvenile idiopathic arthritis
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for experimental group :
child age from 2 to 16 years
Oligoarticular JIA with antinuclear antibodies
with or without uveitis
Exclusion criteria for experimental group :
immunosuppressive and biological therapy
Inclusion Criteria for control group :
child age from 2 to 16 years
Facility Information:
Facility Name
Cardiology paediatric consultation, Arnaud de Villeneuve Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelia CARBASSE, MD
Phone
+33 4 67 33 66 34
Email
a-carbasse@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
aurelia carbasse, MD
12. IPD Sharing Statement
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Biomarkers in Idiopathic Juvenile Arthritis
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