Resumen

El propósito de este estudio es evaluar la eficacia y seguridad del tratamiento con vedolizumab intravenoso (IV) comparado con el tratamiento con adalimumab subcutáneo (SC) durante un período de tratamiento de 52 semanas.

Descripción detallada

El fármaco evaluado en este estudio se llama vedolizumab. Vedolizumab se está estudiando para tratar personas con colitis ulcerosa. Este estudio evaluará la frecuencia de deposiciones, el sangrado rectal y los hallazgos endoscópicos de personas que reciban vedolizumab en comparación con las que reciban adalimumab. El estudio inscribirá aproximadamente 658 participantes. Los participantes serán asignados aleatoriamente (al azar, como al lanzar una moneda) a uno de los dos grupos de tratamiento, que permanecerá sin revelar al paciente y al médico del estudio durante el estudio (a menos que exista una necesidad médica urgente): * Vedolizumab 300 mg IV. * Adalimumab 160 mg el Día 1 seguido de 80 mg en la Semana 2, luego 40 mg cada 2 semanas SC. Todos los participantes recibirán 1 infusión intravenosa el Día 1 y en las Semanas 2, 6, 14, 22, 30, 38 y 46. Todos los participantes también recibirán 4 inyecciones SC el Día 1 o 2 inyecciones SC cada uno los Días 1 y 2, seguidas de 2 inyecciones SC en 1 día en la Semana 2 y luego 1 inyección SC cada 2 semanas hasta la Semana 50. Se solicitará a todos los participantes que registren los síntomas de colitis ulcerosa en un diario diario. Este ensayo multicéntrico se realizará a nivel mundial. El tiempo total de participación en este estudio es de 79 semanas. Los participantes realizarán aproximadamente 11 visitas a la clínica y serán contactados por teléfono 6 meses después de la última dosis del fármaco del estudio para una evaluación de seguimiento.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to \>=2 within 14 days prior to the randomization.
Has evidence of ulcerative colitis proximal to the rectum (\>=15 centimeter \[cm\] of involved colon).
With extensive colitis (up to the hepatic flexure) or pancolitis of \>8 years duration or left-sided colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).
The participant:
Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment (example, due to lack of response \[primary nonresponders\], loss of response, or intolerance \[secondary nonresponders\]), or
Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued its use due to reasons other than safety, or
Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate \[5-ASA\], or immunomodulators).

Criterios de exclusión

Clinical evidence of abdominal abscess or toxic megacolon at Screening.
Has had an extensive colonic resection, subtotal or total colectomy.
Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
Has received any of the following for the treatment of underlying disease within 30 days of randomization:
Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.
An approved non-biologic therapy in an investigational protocol.
Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 antibodies, or rituximab.
Has previously received vedolizumab.
Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
Evidence of an active infection during Screening.
Evidence of, or treatment for, Clostridium difficile (C. difficile) or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
Has chronic hepatitis B virus (HBV) infection\* or chronic hepatitis C virus (HCV) infection (\* HBV immune participants, ie, being hepatitis B surface antigen \[HBsAg\], may participate).
Has active or latent TB, regardless of treatment history.
Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Intervenciones

drug

Vedolizumab

Vedolizumab infusion

drug

Adalimumab placebo

Adalimumab placebo-matching injection

drug

Adalimumab

Adalimumab injection

drug

Vedolizumab placebo

Vedolizumab placebo-matching infusion

Ubicaciones

Instituto de Investigaciones Clinicas-Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto Medico CER

Quilmes, Buenos Aires, Argentina

Expertia S.A- Mautalen Salud e Investigacion

Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Clinicas Instituto del Corazon

Córdoba, Argentina

Patrocinadores

PrincipalTakeda

Estudio multicéntrico, aleatorizado, doble ciego, doble simulación, con control activo para evaluar la eficacia y seguridad de vedolizumab IV comparado con adalimumab SC en sujetos con colitis ulcerosa

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Vedolizumab

Adalimumab placebo

Adalimumab

Vedolizumab placebo

Ubicaciones

Instituto de Investigaciones Clinicas-Mar del Plata

Instituto Medico CER

Expertia S.A- Mautalen Salud e Investigacion

Centro de Investigaciones Clinicas Instituto del Corazon

Patrocinadores