Angiogenic Biomarkers in Juvenile Idiopathic Arthritis (MAJIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Juvenile Idiopathic Arthritis (JIA)
• Intervention / Treatment: Biological: Blood sample; Biological: Joint puncture

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Marie BENHAMMANI-GODARD; Phone Number: +33 1 58411190; Email: marie.godard@aphp.fr
• Study Contact Backup: Name: Yannick ALLANORE, PD, PhD; Phone Number: 0033158412563; Email: yannick.allanore@aphp.fr

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75014
      • Recruiting
      • Rheumatology Department, Cochin Hospital
      • Contact: Yannick ALLANORE, MD, PhD; Phone Number: 0033158412572; Email: yannick.allanore@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: Blood sample; Addtional tube of blood needed for follow up of patients; Biological: Joint puncture; Joint puncture if needed according to routine care of the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Yannick ALLANORE, PD, PhD, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Anticipated): March 1, 2030
• Study Completion (Anticipated): March 1, 2030

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Synovial fluid; 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
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: APHP220364; 2022-A00468-35 (Other Identifier: France : ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No