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Enrolling by Invitation

NCT Number: NCT02377245

Juvenile Inflammatory Rheumatism (JIR) Cohorte

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.

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Key information

Conditions

Arthritis, Juvenile Rheumatoid Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Reine Fabiola, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Michaël Hofer

Other

Collaborators

  • Bicetre Hospital
  • Fondation Rhumatismes-Enfants-Suisse
  • Hospices Civils de Lyon
  • Tenon Hospital, Paris
  • University Hospital Muenster
  • University of Lausanne Hospitals
  • Versailles Hospital

Registry information

Official study title

Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases

Acronym: JIR-cohorte

Important dates

Study start
2014
Primary completion
2028
Study completion
2030
First posted
Mar 3, 2015
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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