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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

Study Description
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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.

Condition or disease
Arthritis, Juvenile Rheumatoid

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 4800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases
Study Start Date : January 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Juvenile Inflammatory Rheumatism
Juvenile Inflammatory Rheumatism patients


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with juvenile inflammatory diseases
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377245


Locations
Show Show 44 study locations
Sponsors and Collaborators
Michaël Hofer
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
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Study Director: Michael Hofer University of Lausanne Hospitals
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Official jir-cohorte project webpage  This link exits the ClinicalTrials.gov site

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Responsible Party: Michaël Hofer, Head of Pediatric Rheumatology unit, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02377245    
Other Study ID Numbers: JIR-001
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Keywords provided by Michaël Hofer, University of Lausanne Hospitals:
Juvenile
Inflammatory
Rheumatism
Pediatric-Onset inflammatory diseases
Additional relevant MeSH terms:
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Arthritis, Juvenile
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases