Clinical trial NCT02377245: Juvenile Inflammatory Rheumatism (JIR) Cohorte
Official title: Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Juvenile
Inflammatory
Rheumatism
Pediatric-Onset inflammatory diseases
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
name: Versailles Hospital
name: Tenon Hospital, Paris
name: Bicetre Hospital
name: University of Lausanne Hospitals
name: University Hospital Muenster
name: Fondation Rhumatismes-Enfants-Suisse
First posted: 2015-03-03
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with juvenile inflammatory diseases

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of severe and very severe adverse event as a mesure of safety and tolerability
timeFrame: 10 years
measure: Number of treatments prescribed off label
timeFrame: 10 Years
measure: Length in months of drug survival in patient treated with at least two consecutive biological agents
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hôpital Reine Fabiola
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC Liège
city: Liège
country: Belgium
facility: CHR Citadelle
city: Belfort
country: France
facility: CHU Belfort
city: Besançon
country: France
facility: CHRU Besançon
city: Bordeaux
country: France
facility: Hôpital Pellegrin enfants
city: Brest
country: France
facility: CHRU Brest
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: Hôpital Nord Marseille
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Mulhouse
country: France
facility: Centre hospitalier de Mulhouse
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: Nice CHU - Lenval
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Hôpital necker Enfants Malade
city: Paris
country: France
facility: Hôpital Robert Debré
city: Paris
country: France
facility: Hôpital Tenon
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: St-Etienne
country: France
facility: CHU St-Etienne
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: Hôpital des enfants
city: Tours
country: France
facility: CHU Tours
city: Versailles
country: France
facility: Hôpital André Mignot
city: Münster
country: Germany
facility: University Hospital Muenster
city: Casablanca
country: Morocco
facility: Hôpital Ibnou Rochd
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Kinderspital Basel
city: Basel
country: Switzerland
facility: Universitäts-Augenklinik Basel
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona e valli
city: Chur
country: Switzerland
facility: Kantonspital Graubunden
city: Lausanne
country: Switzerland
facility: Hôpital Ophtalmique
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Luzern
country: Switzerland
facility: Kinderspital Luzern
city: St-Gallen
country: Switzerland
facility: Ostschweizer Kinderspital St-Gallen
city: Valens
country: Switzerland
facility: Klinik für Rheumatologie und internistische Rehabilitation
city: Winterthur
country: Switzerland
facility: Kantonspital Winterthur
city: Zürich
country: Switzerland
facility: Kinderspital Zürich
Study officials:
affiliation: University of Lausanne Hospitals
name: Michael Hofer
role: STUDY_DIRECTOR
affiliation: Versailles Hospital
name: Véronique Hentgen
role: STUDY_DIRECTOR
References:
citation: 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.