NCT05534347

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Mar 2023Mar 2030

First Submitted

Initial submission to the registry

September 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

7 years

First QC Date

September 6, 2022

Last Update Submit

September 5, 2025

Conditions

Keywords

Juvenile idiopathic arthritis (JIA)JIA patients in transition towards adult wardPrognosis of JIASeverity and structural damage in JIAAngiogenic and inflammatory biomarkersSemaphorin (SEMA4A), CCN1Serum fluidSynovial fluid

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Questionnaires

    5 years

  • Collection of treatments received

    5 years

  • Structural damage determined by x-rays

    5 years

  • Angiogenic biomarkers

    At inclusion

  • Inflammatory biomarkers

    At inclusion

Study Arms (1)

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 sampleBiological: Joint puncture

Interventions

Blood sampleBIOLOGICAL

Addtional tube of blood needed for follow up of patients

Juvenile Idiopathic Arthritis
Joint punctureBIOLOGICAL

Joint puncture if needed according to routine care of the patients

Juvenile Idiopathic Arthritis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Patient under curatorship or guardianship
  • Patient receiving french state medical aid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Department, Cochin Hospital

Paris, IDF, 75014, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Serum samples * Synovial fluid samples

MeSH Terms

Conditions

Arthritis, JuvenileCone-Rod Dystrophy 10Cornea Plana 1

Interventions

Blood Specimen CollectionArthrocentesis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesParacentesisTherapeutics

Study Officials

  • Yannick ALLANORE, PD, PhD

    Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick ALLANORE, PD, PhD

CONTACT

Marie BENHAMMANI-GODARD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 9, 2022

Study Start

March 13, 2023

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations