Septic ArthritisARTEMISNCT02505828
ARTEMIS Synovial Markers in Arthritis Childhood
A study testing Articular punction, salivary samples, blood sample in people with Septic Arthritis and Juvenile Idiopathic Arthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Septic Arthritis, Juvenile Idiopathic Arthritis
- What is being tested?
- Articular punction, salivary samples, blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Apr 2018
- Phase
- Interventional
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Septic Arthritis, Juvenile Idiopathic Arthritis
- Being tested
- Articular punction, salivary samples, blood sample
- Keywords
- Arthritis, septic, Juvenile idiopathic arthritis, diagnosis, proteomic, cytokine, monocytes
- Medical subject headings
- Arthritis, Infectious, Arthritis, Juvenile, Arthritis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articular punction, salivary samples, blood sampleProcedure or surgery
Also called Proteomic analysis, Cytokine dosage, Monocyte
| Study group | Role | What they receive |
|---|---|---|
| Septic arthritis | Other | with bacteriological identification Receives: Procedure: Articular punction, salivary samples, blood sample |
| Juvenile idiopathic arthritis | Other | beyond the ILAR (International League of Associations for Rheumatology) definition Receives: Procedure: Articular punction, salivary samples, blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative analysis of new biological markers (proteic, cytokine or cellular) that discriminate inflammatory and infectious arthritis.
Identify blood sampling biomarkers of Arthritis childhood
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric EJ JEZIORSKI, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505828
- Sponsor's protocol ID
- 93612
- Other IDs
- 2014-A01561-46
- Acronym
- ARTEMIS
- Status last verified
- Dec 2020
- First submitted
- 22 Jun 2015
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31779271Cren 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.
PubMed 32849606
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTEMIS Synovial Markers in Arthritis Childhood
- ClinicalTrials.gov ID
- NCT02505828
- Acronym / sponsor ID
- ARTEMIS / 93612
- Conditions
- Septic Arthritis, Juvenile Idiopathic Arthritis
- Keywords
- Arthritis, septic, Juvenile idiopathic arthritis, diagnosis, proteomic, cytokine, monocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 22 Jul 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic arthritis | Other | Procedure: Articular punction, salivary samples, blood samplewith bacteriological identification |
| Juvenile idiopathic arthritis | Other | Procedure: Articular punction, salivary samples, blood samplebeyond the ILAR (International League of Associations for Rheumatology) definition |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Articular punction, salivary samples, blood sampleAlso: Proteomic analysis, Cytokine dosage, Monocyte | Procedure or surgery | Juvenile idiopathic arthritis, Septic arthritis |
Primary outcome
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
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 31 Dec 2020.
- Results publication: PubMed 31779271Nziza 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.
- Results publication: PubMed 32849606Cren 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.
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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.
Eric EJ JEZIORSKI, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articular punction, salivary samples, blood sample in people with Septic Arthritis and Juvenile Idiopathic Arthritis, run by University Hospital, Montpellier at 1 site 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 5 inclusion and 3 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Qualitative analysis of new biological markers (proteic, cytokine or cellular) that discriminate inflammatory and infectious arthritis. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505828, which also lists 2 linked publications.
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 31 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.