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Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease

Overview

Información sobre este estudio

The purpose of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with inflammatory bowel disease (IBD) who received a COVID-19 vaccine.  This observational study will collect blood samples to measure sustained antibody concentrations to evaluate seroprevalence and study immunity  at 6 and 12 months after completion of vaccination.  The primary outcome of this study is to evaluate the immunogenicity of the Covid-19 vaccine in patients with IBD.

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:

  • Adults with established inflammatory bowel disease, age 18-85 years.
  • On one of the following treatment regimens at both the time of immunization and at time of recruitment:
    • Group A non-biologic group: mesalamine monotherapy or thiopurine monotherapy, or corticosteroids.
    • Group B: Anti-TNF Therapy Group:
      • Maintenance monotherapy: infliximab (at least 8 every 8 weeks), golilumumab (at least monthly), adalilumab (at least every 2 weeks), or certolizumab (at least monthly);
      • Combination Therapy: Anti-TNF Combination Therapy Group (approximately 40-50% of the group): on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg.
    • Group C: Ustekinumab on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
    • Group D: Vedolizumab Therapy Group: Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine.

Exclusion Criteria:

  • Individuals under 18 or over 85 years of age.
  • Not diagnosed with inflammatory bowel disease.

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

Jacksonville, Fla.

Investigador principal de Mayo Clinic

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

Abierto para la inscripción

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20542399

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