Juvenile Idiopathic Arthritis (JIA)MAJICNCT05534347
Angiogenic Biomarkers in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to determine whether serum inflammatory angiogenic markers (eg, semaphorins, CCN1) predict severity of juvenile idiopathic arthritis defined by structural progression and/or therapeutic escalation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- What is being tested?
- Blood sample and Joint puncture
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2023to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients over (or egal) 16 years old with diagnosis of Juvenile Idiopathic Arthritis starting their follow up in adult rheumatology ward in Cochin hospital
Who may be able to join
- Greater than or equal to 16 years-old
- Diagnosis of Juvenile Idiopathic Arthritis with specialized follow up in Rheumatology at Cochin Hospital
- No-opposition to the research
- Patient with health insurance
- Mastery of the French language
Who cannot join
- Patient under curatorship or guardianship
- Patient receiving french state medical aid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rheumatology Department, Cochin Hospital
Paris, IDF, 75014
Yannick ALLANORE, MD, PhD, 0033158412572, yannick.allanore@aphp.fr
About this study
Official title: Angiogenic Inflammatory Biomarkers in Juvenile Idiopathic Arthritis
The aim of the study is to determine whether serum inflammatory angiogenic markers (eg, semaphorins, CCN1) predict severity of juvenile idiopathic arthritis defined by structural progression and/or therapeutic escalation.
Read the detailed description
Juvenile idiopathic arthritis (JIA) is a heterogeneous group of chronic inflammatory rheumatic diseases beginning before the age of 16. The most common pediatric rheumatologic disease. JIA is the most common pediatric rheumatologic disease. Apart from clinical features and the biological inflammatory syndrome, no predictive parameter for the severity of JIA, especially polyarticular JIA, has been identified. The team has been interested in the prognosis of RA for many years. Thus, the investigators have conducted various studies in search of biological parameters associated with the joint prognosis of RA patients, which allowed the investigator to discover the interest of angiogenic and inflammatory biomarkers such as semaphorins and CCN1 protein. This has been demonstrated in vitro but also in vivo from sera of RA patients. These markers are associated with activity and structural damage in RA.
The project aims to study the interest of these same angiogenic biomarkers in the serum of JIA patients in order to establish whether, as in RA, they are also associated with disease severity.
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Being tested
- Blood sample, Joint puncture
- Keywords
- Juvenile idiopathic arthritis (JIA), JIA patients in transition towards adult ward, Prognosis of JIA, Severity and structural damage in JIA, Angiogenic and inflammatory biomarkers, Semaphorin (SEMA4A), CCN1, Serum fluid, Synovial fluid
- Medical subject headings
- Arthritis, Juvenile, Cone-Rod Dystrophy 10, Cornea Plana 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Addtional tube of blood needed for follow up of patients
Joint punctureBiological
Joint puncture if needed according to routine care of the patients
| Study group | Role | What they receive |
|---|---|---|
| Juvenile Idiopathic Arthritis | Patients seen in a specialized rheumatology consultation for the management of juvenile idiopathic arthritis in an adult service, after information and collection of their non-opposition. Receives: Biological: Blood sample; Biological: Joint puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of angiogenic markers
Dosage of angiogenic markers by ELISA method in serum. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received.
Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
Measured: 5 years
Dosage of angiogenic markers
Dosage of angiogenic markers by ELISA method in synovial fluid if available. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received.
Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
Measured: 5 years
Dosage of inflammatory markers by ELISA method
Dosage of inflammatory markers by ELISA method in serum. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received.
Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
Measured: 5 years
Dosage of inflammatory markers by ELISA method
Dosage of inflammatory markers by ELISA method in synovial fluid if available. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received.
Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
Measured: 5 years
Secondary outcomes (5)
Questionnaires
Severity of JIA
Measured: 5 years
Collection of treatments received
Severity of JIA
Measured: 5 years
Structural damage determined by x-rays
Structural damage determined by x-rays during follow up.
Measured: 5 years
Angiogenic biomarkers
Determine if sera angiogenic biomarkers are associated with clinical subtypes of JIA.
Measured: At inclusion
Inflammatory biomarkers
Determine if sera inflammatory biomarkers are associated with clinical subtypes of JIA.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start13 Mar 2023
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yannick ALLANORE, PD, PhD, Principal investigator, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534347
- Sponsor's protocol ID
- APHP220364
- Other IDs
- 2022-A00468-35
- Acronym
- MAJIC
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogenic Inflammatory Biomarkers in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05534347
- Acronym / sponsor ID
- MAJIC / APHP220364
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- Juvenile idiopathic arthritis (JIA), JIA patients in transition towards adult ward, Prognosis of JIA, Severity and structural damage in JIA, Angiogenic and inflammatory biomarkers, Semaphorin (SEMA4A), CCN1, Serum fluid, Synovial fluid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 9 Sep 2022 (actual)
- 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 the study is to determine whether serum inflammatory angiogenic markers (eg, semaphorins, CCN1) predict severity of juvenile idiopathic arthritis defined by structural progression and/or therapeutic escalation.
Detailed description
Juvenile idiopathic arthritis (JIA) is a heterogeneous group of chronic inflammatory rheumatic diseases beginning before the age of 16. The most common pediatric rheumatologic disease. JIA is the most common pediatric rheumatologic disease. Apart from clinical features and the biological inflammatory syndrome, no predictive parameter for the severity of JIA, especially polyarticular JIA, has been identified. The team has been interested in the prognosis of RA for many years. Thus, the investigators have conducted various studies in search of biological parameters associated with the joint prognosis of RA patients, which allowed the investigator to discover the interest of angiogenic and inflammatory biomarkers such as semaphorins and CCN1 protein. This has been demonstrated in vitro but also in vivo from sera of RA patients. These markers are associated with activity and structural damage in RA.
The project aims to study the interest of these same angiogenic biomarkers in the serum of JIA patients in order to establish whether, as in RA, they are also associated with disease severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvenile Idiopathic Arthritis | – | Biological: Blood sample, Biological: Joint puncturePatients seen in a specialized rheumatology consultation for the management of juvenile idiopathic arthritis in an adult service, after information and collection of their non-opposition. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients over (or egal) 16 years old with diagnosis of Juvenile Idiopathic Arthritis starting their follow up in adult rheumatology ward in Cochin hospital
Key inclusion criteria (5 listed)
- Greater than or equal to 16 years-old
- Diagnosis of Juvenile Idiopathic Arthritis with specialized follow up in Rheumatology at Cochin Hospital
- No-opposition to the research
- Patient with health insurance
- Mastery of the French language
Key exclusion criteria (2 listed)
- Patient under curatorship or guardianship
- Patient receiving french state medical aid
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 |
|---|---|---|
| Blood sampleAddtional tube of blood needed for follow up of patients | Biological | Juvenile Idiopathic Arthritis |
| Joint punctureJoint puncture if needed according to routine care of the patients | Biological | Juvenile Idiopathic Arthritis |
Primary outcome
Dosage of angiogenic markers
Time frame: 5 years
Dosage of angiogenic markers by ELISA method in serum. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received. Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
Dosage of angiogenic markers
Time frame: 5 years
Dosage of angiogenic markers by ELISA method in synovial fluid if available. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received. Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
Dosage of inflammatory markers by ELISA method
Time frame: 5 years
Dosage of inflammatory markers by ELISA method in serum. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received. Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
Dosage of inflammatory markers by ELISA method
Time frame: 5 years
Dosage of inflammatory markers by ELISA method in synovial fluid if available. Determine if angiogenic and inflammatory biomarkers are predictive of a more severe disease as reflected by structural joint damage and treatments received. Activity measured with questionnaires, and treatments received. Structural damage determined by x-rays during follow up.
5 secondary outcomes
Questionnaires
Time frame: 5 years
Collection of treatments received
Time frame: 5 years
Structural damage determined by x-rays
Time frame: 5 years
Angiogenic biomarkers
Time frame: At inclusion
Inflammatory biomarkers
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Yannick ALLANORE, PD, PhD principal investigator
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Assistance Publique - Hôpitaux de Paris 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 2 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannick ALLANORE, PD, PhD (0033158412563, yannick.allanore@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of angiogenic markers (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.