SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry

Overview

Información sobre este estudio

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and it's objective is to monitor patients for approximately 10 years.

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.

This study is enrolling participants by invitation only.

Inclusion Criteria:

  • Patient must have medically documented Crohn's disease
  • The decision to prescribe Cimzia or other medications has been made by the physician independent of inclusion in this study
  • Patient (or his/her legally acceptable representative) is able to provide written informed consent to permit collection of data
  • Patients participating in randomized, blinded clinical trials for CD or other conditions are not eligible for inclusion into the SECURE registry. Involvement in other registries, where patients follow routine clinical practice, is permitted, however
  • For the Cimzia cohort: Patient is receiving treatment with Cimzia for the first time. Patient must receive Cimzia treatment within 2 months of enrollment into the registry
  • Patient is currently receiving treatment with Cimzia for ≤12 months. Patient must also receive a Cimzia dose within 2 months following enrollment into the registry
  • For the comparison cohort: Patient is switching CD treatment or beginning CD treatment for the first time. Previous Cimzia treatment is prohibited in the comparator group. Patient must receive new CD treatment within 2 months of enrollment into the registry. Patient is currently receiving anti-TNF treatment for ≤12 months. Patient must receive anti-TNF treatment within 2 months following enrollment into the registry. Patient is currently receiving immunosuppressant therapy for ≤12 months. Patient must receive immunosuppressant therapy within 2 months following enrollment into the registry. Patient is currently receiving systemic steroid therapy for ≤12 months. Patient must receive systemic steroid therapy within 2 months following enrollment into registry

Exclusion Criteria:

  • See inclusion criteria

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

Rochester, Minn.

Investigador principal de Mayo Clinic

Edward Loftus, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20310173

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