A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03345823Tipo: INTERVENTIONALInicio: 21 de mar de 2018Fin estimado: 1 de sept de 2027

Traducción no disponible, mostrando original

Resumen

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

For Substudy 1:
Participant who achieve clinical response in Study M14-431 or Study M14-433.
Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
For Substudy 2:
Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Criterios de exclusión

For Substudies 1 and 2:
Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

Intervenciones

drug

Upadacitinib

Oral; Tablet

drug

Placebo for Upadacitinib

Oral; Tablet

Ubicaciones

Cemic /Id# 169183

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Cardio Alem /ID# 211283

San Isidro, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires /ID# 215542

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

Gedyt /ID# 210018

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Hospital Provincial del Centenario /ID# 171251

Rosario, Santa Fe Province, Argentina

Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 169229

Córdoba, Argentina

Patrocinadores

PrincipalAbbVie

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