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Enrolling by invitationNCT02377245JIR-cohorteUpdated Jun 15, 2023

Juvenile Inflammatory Rheumatism (JIR) Cohorte

An observational study in Arthritis, Juvenile Rheumatoid, sponsored by Michaël Hofer. Enrolling by invitation at 45 sites in 5 countries. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Michaël Hofer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15,000
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Arthritis, Juvenile Rheumatoid

Keywords

  • Juvenile
  • Inflammatory
  • Rheumatism
  • Pediatric-Onset inflammatory diseases
03

In context

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 120 across 118 observational studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

This is the only study on the registry with Michaël Hofer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with juvenile inflammatory diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Non-consent from patients and/or legal representative
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Juvenile Inflammatory Rheumatism

    Juvenile Inflammatory Rheumatism patients

06

What researchers measure

Primary outcomes

  1. Number of severe and very severe adverse event as a mesure of safety and tolerability

    Time frame: 10 years

  2. Number of treatments prescribed off label

    Time frame: 10 Years

  3. Length in months of drug survival in patient treated with at least two consecutive biological agents

    Time frame: 10 Years

07

Study locations

45 sites
08

References and documents

Publications

  • Pouletty M, Borocco C, Ouldali N, Caseris M, Basmaci R, Lachaume N, Bensaid P, Pichard S, Kouider H, Morelle G, Craiu I, Pondarre C, Deho A, Maroni A, Oualha M, Amoura Z, Haroche J, Chommeloux J, Bajolle F, Beyler C, Bonacorsi S, Carcelain G, Kone-Paut I, Bader-Meunier B, Faye A, Meinzer U, Galeotti C, Melki I. Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 mimicking Kawasaki disease (Kawa-COVID-19): a multicentre cohort. Ann Rheum Dis. 2020 Aug;79(8):999-1006. doi: 10.1136/annrheumdis-2020-217960. Epub 2020 Jun 11. PubMed 32527868 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Dec 2028 and a completion of Dec 2030. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2014
First posted
Mar 3, 2015
Start
Jan 2014
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2030
Last update
Jun 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02377245
Lead sponsor
Michaël Hofer
Collaborators
Hospices Civils de Lyon, Versailles Hospital, Tenon Hospital, Paris, Bicetre Hospital, University of Lausanne Hospitals, University Hospital Muenster, Fondation Rhumatismes-Enfants-Suisse
Responsible party
Michaël Hofer (Head of Pediatric Rheumatology unit, University of Lausanne Hospitals) — Sponsor-investigator
First posted
Mar 3, 2015
Start date
Jan 2014
Primary completion
Dec 2028 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jun 15, 2023

Study contacts

Michael Hofer
study director · University of Lausanne Hospitals
Véronique Hentgen
study director · Versailles Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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