- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02505828
ARTEMIS Synovial Markers in Arthritis Childhood (ARTEMIS)
December 29, 2020 updated by: University Hospital, Montpellier
The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis.
The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis.
The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis.
The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Montpellier, France, 34295
- Hôpital Arnaud de Villeneuve
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Septic arthritis with bacteriological identification
- Juvenile idiopathic arthritis beyond the ILAR definition
- Having acute arthritis requiring an articular draining
- Child benefiting from a national insurance scheme
- Collection of the consent of the parents or the legal representative
Exclusion Criteria:
- Contraindication in an articular draining: platelet 50 000 / mm3, Rate of prothrombins lower than 70 %, activated partial thromboplastin times (APTT)> 1,5
- Treatment by biotherapy, corticoids or other immuno suppressor in the month preceding the articular draining.
- Treatment by antibiotic begun more than 24 hours before the draining.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Septic arthritis
with bacteriological identification
|
Other Names:
|
Other: Juvenile idiopathic arthritis
beyond the ILAR (International League of Associations for Rheumatology) definition
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative analysis of new biological markers (proteic, cytokine or cellular) that discriminate inflammatory and infectious arthritis.
Time Frame: 1 day
|
Identify blood sampling biomarkers of Arthritis childhood
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1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric EJ JEZIORSKI, MD, PhD, Montpellier University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nziza N, Jeziorski E, Delpont M, Cren M, Chevassus H, Carbasse A, Mahe P, Abassi H, Joly-Monrigal P, Schordan E, Mange A, Jorgensen C, Apparailly F, Duroux-Richard I. Synovial-Fluid miRNA Signature for Diagnosis of Juvenile Idiopathic Arthritis. Cells. 2019 Nov 26;8(12):1521. doi: 10.3390/cells8121521.
- Cren M, Nziza N, Carbasse A, Mahe P, Dufourcq-Lopez E, Delpont M, Chevassus H, Khalil M, Mura T, Duroux-Richard I, Apparailly F, Jeziorski E, Louis-Plence P. Differential Accumulation and Activation of Monocyte and Dendritic Cell Subsets in Inflamed Synovial Fluid Discriminates Between Juvenile Idiopathic Arthritis and Septic Arthritis. Front Immunol. 2020 Jul 31;11:1716. doi: 10.3389/fimmu.2020.01716. eCollection 2020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
June 22, 2015
First Submitted That Met QC Criteria
July 20, 2015
First Posted (Estimate)
July 22, 2015
Study Record Updates
Last Update Posted (Actual)
December 31, 2020
Last Update Submitted That Met QC Criteria
December 29, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 93612
- 2014-A01561-46 (Registry Identifier: ID RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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