NCT02377245

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.

Trial Health

82
On Track

Trial Health Score

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

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
5 countries

45 active sites

Status
enrolling by invitation

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 Progress73%
Jan 2014Dec 2030

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

14.9 years

First QC Date

October 9, 2014

Last Update Submit

June 12, 2023

Conditions

Keywords

JuvenileInflammatoryRheumatismPediatric-Onset inflammatory diseases

Outcome Measures

Primary Outcomes (3)

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

    10 years

  • Number of treatments prescribed off label

    10 Years

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

    10 Years

Study Arms (1)

Juvenile Inflammatory Rheumatism

Juvenile Inflammatory Rheumatism patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with juvenile inflammatory diseases

You may qualify if:

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

You may not qualify if:

  • Non-consent from patients and/or legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Hôpital Reine Fabiola

Brussels, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHC Liège

Liège, Belgium

Location

CHR Citadelle

Liège, Belgium

Location

CHU Belfort

Belfort, France

Location

CHRU Besançon

Besançon, France

Location

Hôpital Pellegrin enfants

Bordeaux, 33000, France

Location

CHRU Brest

Brest, France

Location

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Grenoble

Grenoble, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHRU Lille

Lille, France

Location

Hôpital Nord Marseille

Marseille, France

Location

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

Centre hospitalier de Mulhouse

Mulhouse, 68100, France

Location

CHU Nantes

Nantes, France

Location

Nice CHU - Lenval

Nice, France

Location

CHU Nimes

Nîmes, France

Location

Hôpital necker Enfants Malade

Paris, France

Location

Hôpital Robert Debré

Paris, France

Location

Hôpital Tenon

Paris, France

Location

CHU Reims

Reims, France

Location

CHU Rennes

Rennes, France

Location

CHU St-Etienne

Saint-Etienne, France

Location

Hôpital de Hautepierre

Strasbourg, 67100, France

Location

Hôpital des enfants

Toulouse, 31059, France

Location

CHU Tours

Tours, France

Location

Hôpital André Mignot

Versailles, 78157, France

Location

University Hospital Muenster

Münster, Germany

Location

Hôpital Ibnou Rochd

Casablanca, 20042, Morocco

Location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Kantonsspital Aarau

Aarau, 5000, Switzerland

Location

Kinderspital Basel

Basel, 4056, Switzerland

Location

Universitäts-Augenklinik Basel

Basel, Switzerland

Location

Ospedale Regionale di Bellinzona e valli

Bellinzona, Switzerland

Location

Kantonspital Graubunden

Chur, 7000, Switzerland

Location

Hôpital Ophtalmique

Lausanne, 1004, Switzerland

Location

Kinderspital Luzern

Lucerne, 6000, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, Switzerland

Location

Ostschweizer Kinderspital St-Gallen

Sankt Gallen, Switzerland

Location

Klinik für Rheumatologie und internistische Rehabilitation

Valens, 7317, Switzerland

Location

Kantonspital Winterthur

Winterthur, Switzerland

Location

Kinderspital Zürich

Zurich, 8032, Switzerland

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Arthritis, JuvenileRheumatic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael Hofer

    University of Lausanne Hospitals

    STUDY DIRECTOR
  • Véronique Hentgen

    Versailles Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Pediatric Rheumatology unit

Study Record Dates

First Submitted

October 9, 2014

First Posted

March 3, 2015

Study Start

January 1, 2014

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations