Juvenile Inflammatory Rheumatism (JIR) Cohorte (JIR-cohorte)

June 12, 2023 updated by: Michaël Hofer

Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases

The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

The JIR-cohort has to be filled by an authorized investigator during or after the consultation. Each patient much be followed at least once a year.

Different data are requested in the JIR-cohort: diagnosis, treatment, adverse events and outcome.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Hôpital Reine Fabiola
      • Charleroi, Belgium
        • Chu Charleroi
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium
        • CHR Citadelle
      • Liège, Belgium
        • CHC Liège
  • France
      • Belfort, France
        • CHU Belfort
      • Besançon, France
        • CHRU Besançon
      • Bordeaux, France, 33000
        • Hôpital Pellegrin enfants
      • Brest, France
        • CHRU Brest
      • Bron, France, 69677
        • Hôpital Femme Mère Enfant
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand
      • Grenoble, France
        • Chu de Grenoble
      • Le Kremlin Bicêtre, France, 94270
        • Hôpital Bicêtre
      • Lille, France
        • CHRU Lille
      • Marseille, France
        • Hôpital Nord Marseille
      • Montpellier, France, 34295
        • CHU Arnaud de Villeneuve
      • Mulhouse, France, 68100
        • Centre Hospitalier de Mulhouse
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • Nice CHU - Lenval
      • Nimes, France
        • CHU Nîmes
      • Paris, France
        • Hopital Robert Debre
      • Paris, France
        • Hôpital Tenon
      • Paris, France
        • Hôpital necker Enfants Malade
      • Reims, France
        • CHU Reims
      • Rennes, France
        • CHU Rennes
      • St-Etienne, France
        • CHU St-Etienne
      • Strasbourg, France, 67100
        • Hopital de Hautepierre
      • Toulouse, France, 31059
        • Hôpital des Enfants
      • Tours, France
        • Chu Tours
      • Versailles, France, 78157
        • Hôpital André Mignot
  • Germany
      • Münster, Germany
        • University Hospital Muenster
  • Morocco
      • Casablanca, Morocco, 20042
        • Hôpital Ibnou Rochd
  • Switzerland
      • Aarau, Switzerland, 5000
        • Kantonsspital Aarau
      • Basel, Switzerland, 4056
        • Kinderspital Basel
      • Basel, Switzerland
        • Universitäts-Augenklinik Basel
      • Bellinzona, Switzerland
        • Ospedale Regionale di Bellinzona e Valli
      • Chur, Switzerland, 7000
        • Kantonspital Graubunden
      • Lausanne, Switzerland, 1004
        • Hôpital Ophtalmique
      • Lugano, Switzerland
        • Ospedale Regionale di Lugano
      • Luzern, Switzerland, 6000
        • Kinderspital Luzern
      • St-Gallen, Switzerland
        • Ostschweizer Kinderspital St-Gallen
      • Valens, Switzerland, 7317
        • Klinik für Rheumatologie und internistische Rehabilitation
      • Winterthur, Switzerland
        • Kantonspital Winterthur
      • Zürich, Switzerland, 8032
        • Kinderspital Zürich
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with juvenile inflammatory diseases

Description

Inclusion Criteria:

  • Patients with juvenile inflammatory diseases
  • Age at onset up to 18 years old
  • Consent according national codes of ethics and current laws

Exclusion Criteria:

  • Non-consent from patients and/or legal representative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Juvenile Inflammatory Rheumatism
Juvenile Inflammatory Rheumatism patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of severe and very severe adverse event as a mesure of safety and tolerability
Time Frame: 10 years
10 years
Number of treatments prescribed off label
Time Frame: 10 Years
10 Years
Length in months of drug survival in patient treated with at least two consecutive biological agents
Time Frame: 10 Years
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michaël Hofer

Collaborators

Hospices Civils de Lyon
University Hospital Muenster
Versailles Hospital
University of Lausanne Hospitals
Bicetre Hospital
Tenon Hospital, Paris
Fondation Rhumatismes-Enfants-Suisse

Investigators

  • Study Director: Michael Hofer, University of Lausanne Hospitals
  • Study Director: Véronique Hentgen, Versailles Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimated)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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