A Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease

Overview

Información sobre este estudio

The purpose of this study is to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active crohn's disease

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • For the HUMIRA treatment group
    • Children between the ages of 6 and 17 years inclusive at the time of enrollment
    • Diagnosed with moderately to severely active Crohn's Disease
    • Has been prescribed Humira therapy according to the local approved Humira product label
  • For the immunosuppressant therapy treatment group
    • Children between the ages of 6 and 17 years inclusive at the time of enrollment
    • Diagnosed with moderately to severely active Crohn's Disease
    • Has been prescribed azathioprine, 6-mercaptopurine or methotrexate
  • Parent or guardian or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric Crohn's Disease investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data informed consent form after the nature of the registry has been explained and there has been the opportunity to ask questions

Exclusion Criteria

  • Cannot be treated in accordance with the local Humira product label
  • Is currently being treated with any investigational agents or is receiving any investigational procedures
  • Should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Michael Stephens, M.D.

Cerrado para la inscripción

Contact information:

Janell Ellenbecker

(507) 284-0523

Ellenbecker.Janell@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20272694

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