A Study to Evaluate TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD)

Overview

Información sobre este estudio

The purpose of this study is to evaluate the effectiveness of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.

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:

  • Must have a documented diagnosis of CD confirmed by endoscopic biopsy before resection or by tissue obtained at resection.
  • Planned to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before randomization Day 1. Confirmation that no active disease has been left behind after resection will be based on surgeon's documentation in the operative report.
  • With postoperative discontinuation of all concomitant medications specifically related to the treatment of CD. This includes anti-tumor necrosis factor-alpha (TNF-α) and anti-integrin therapy, anti- interleukin (IL) 12/23, thiopurines and other immunomodulators, steroids, 5-minosalicylates, and prophylactic use of antibiotics for the prevention of postoperative recurrence such as metronidazole.
  • Has resumed oral intake and is capable of swallowing tablets after surgery.

Exclusion Criteria:

  • Has active perianal CD.
  • Has had > 3 previous surgical procedures for CD.
  • Has macroscopically active CD that was not resected at the time of surgery as documented in the surgeon's operative report.
  • With small bowel resection that exceeds 100 centimeter (cm) or a participant who is considered at risk of short bowel syndrome by the surgeon or investigator.
  • Has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
    • history of tuberculosis; OR
    • positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests; OR
    • a tuberculin skin test reaction ≥ 10 millimeter (mm) (≥ 5 mm in participants receiving the equivalent of >15 milligram per day (mg/day) prednisone).
  • Has chronic hepatitis B (hepatitis B surface antigen positive, or positive for both hepatitis B surface antibody and hepatitis B core antibody but negative for hepatitis B surface antigen) or hepatitis C infection (evident by viral replication by polymerase chain reaction) within 30 days of randomization.

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

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Francis Farraye, M.D., M.S.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20510639

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