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Clinical Trials/NCT02377245
NCT02377245
Enrolling By Invitation
Not Applicable

Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases

Michaël Hofer45 sites in 5 countries15,000 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis, Juvenile Rheumatoid
Sponsor
Michaël Hofer
Enrollment
15000
Locations
45
Primary Endpoint
Number of treatments prescribed off label
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2030
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Michaël Hofer
Responsible Party
Sponsor Investigator
Principal Investigator

Michaël Hofer

Head of Pediatric Rheumatology unit

University of Lausanne Hospitals

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

Outcomes

Primary Outcomes

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

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

Time Frame: 10 years

Study Sites (45)

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