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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377245
Recruitment Status : Enrolling by invitation
First Posted : March 3, 2015
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Hospices Civils de Lyon
University Children's Hospital Basel
Versailles Hospital
Hôpital Necker-Enfants Malades
Tenon Hospital, Paris
Bicetre Hospital
University of Lausanne Hospitals
University Hospital Muenster
University of Bordeaux
Information provided by (Responsible Party):
Michaël Hofer, University of Lausanne Hospitals

Tracking Information
First Submitted Date October 9, 2014
First Posted Date March 3, 2015
Last Update Posted Date April 25, 2019
Study Start Date January 2014
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2015)
  • Number of severe and very severe adverse event as a mesure of safety and tolerability [ Time Frame: 10 years ]
  • Number of treatments prescribed off label [ Time Frame: 10 Years ]
  • Length in months of drug survival in patient treated with at least two consecutive biological agents [ Time Frame: 10 Years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Juvenile Inflammatory Rheumatism (JIR) Cohorte
Official Title Setting up a Pediatric Cohort for Inflammatory Rheumatic 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with juvenile inflammatory diseases
Condition Arthritis, Juvenile Rheumatoid
Intervention Not Provided
Study Groups/Cohorts Juvenile Inflammatory Rheumatism
Juvenile Inflammatory Rheumatism patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Actual Enrollment
 (submitted: April 23, 2019)
4800
Original Estimated Enrollment
 (submitted: February 24, 2015)
1000
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Belgium,   Germany,   Morocco,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02377245
Other Study ID Numbers JIR-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michaël Hofer, University of Lausanne Hospitals
Study Sponsor Michaël Hofer
Collaborators
  • Hospices Civils de Lyon
  • University Children's Hospital Basel
  • Versailles Hospital
  • Hôpital Necker-Enfants Malades
  • Tenon Hospital, Paris
  • Bicetre Hospital
  • University of Lausanne Hospitals
  • University Hospital Muenster
  • University of Bordeaux
Investigators
Study Director: Michael Hofer University of Lausanne Hospitals
PRS Account University of Lausanne Hospitals
Verification Date April 2019