MAJIC: Angiogenic Biomarkers in Juvenile Idiopathic Arthritis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534347
Collaborator
(none)
300
1
84
3.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Angiogenic Inflammatory Biomarkers in Juvenile Idiopathic Arthritis
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2029
Anticipated Study Completion Date :
Sep 1, 2029

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Dosage of angiogenic markers [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.

  2. Dosage of angiogenic markers [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.

  3. Dosage of inflammatory markers by ELISA method [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.

  4. Dosage of inflammatory markers by ELISA method [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.

Secondary Outcome Measures

  1. Questionnaires [5 years]

    Severity of JIA

  2. Collection of treatments received [5 years]

    Severity of JIA

  3. Structural damage determined by x-rays [5 years]

    Structural damage determined by x-rays during follow up.

  4. Angiogenic biomarkers [At inclusion]

    Determine if sera angiogenic biomarkers are associated with clinical subtypes of JIA.

  5. Inflammatory biomarkers [At inclusion]

    Determine if sera inflammatory biomarkers are associated with clinical subtypes of JIA.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rheumatology Department, Cochin Hospital Paris IDF France 75014

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05534347
Other Study ID Numbers:
  • APHP220364
  • 2022-A00468-35
First Posted:
Sep 9, 2022
Last Update Posted:
Sep 9, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2022