Angiogenic Biomarkers in Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA) Clinical Trial

— MAJIC  

Official title:

Angiogenic Inflammatory Biomarkers in Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534347
• Other study ID #: APHP220364
• Secondary ID: 2022-A00468-35
• Status: Recruiting
• Start date: March 13, 2023
• Est. completion date: March 2030

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Yannick ALLANORE, PD, PhD
• Phone: 0033158412563
• Email: yannick.allanore[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient under curatorship or guardianship

• Patient receiving french state medical aid

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis (JIA)

Intervention

Biological:
• Blood sample
Addtional tube of blood needed for follow up of patients
• Joint puncture
Joint puncture if needed according to routine care of the patients

Locations

Country	Name	City	State
France	Rheumatology Department, Cochin Hospital	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Primary	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.	5 years
Primary	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.	5 years
Primary	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.	5 years
Secondary	Questionnaires	Severity of JIA	5 years
Secondary	Collection of treatments received	Severity of JIA	5 years
Secondary	Structural damage determined by x-rays	Structural damage determined by x-rays during follow up.	5 years
Secondary	Angiogenic biomarkers	Determine if sera angiogenic biomarkers are associated with clinical subtypes of JIA.	At inclusion
Secondary	Inflammatory biomarkers	Determine if sera inflammatory biomarkers are associated with clinical subtypes of JIA.	At inclusion