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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Liege
  • France
      • Belfort, France
        • CHU Belfort
      • Besançon, France
        • CHRU Besançon
      • Bordeaux, France, 33000
        • Hôpital Pellegrin enfants
      • Brest, France
        • CHRU Brest
      • Bron, France, 69677
        • Hopital Femme Mere 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
        • Hopital Necker Enfants Malade
      • Reims, France
        • CHU Reims
      • Rennes, France
        • Chu Rennes
      • St-Etienne, France
        • Chu St-Etienne
      • Strasbourg, France, 67100
        • Hôpital de Hautepierre
      • Toulouse, France, 31059
        • Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Juvenile Inflammatory Rheumatism
Juvenile Inflammatory Rheumatism patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michaël Hofer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospices Civils de Lyon
University Hospital Muenster
Versailles Hospital
University of Lausanne Hospitals
Bicetre Hospital
Tenon Hospital, Paris
Fondation Rhumatismes-Enfants-Suisse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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