A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

TerminadoFase 3ClinicalTrials.gov

ID: NCT03467958Tipo: INTERVENTIONALInicio: 24 de ago de 2018Fin estimado: 31 de oct de 2024

Traducción no disponible, mostrando original

Resumen

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
Experience relapse or who complete the Maintenance Study
Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation

Criterios de exclusión

Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors

Intervenciones

drug

Ozanimod

Specified dose on specified days

Ubicaciones

Local Institution - 501

Buenos Aires, Argentina

Local Institution - 494

Buenos Aires, Argentina

Local Institution - 571

Buenos Aires, Argentina

Local Institution - 500

Buenos Aires, Argentina

Local Institution - 570

Córdoba, Argentina

Local Institution - 495

Córdoba, Argentina

Local Institution - 569

Mar del Plata, Argentina

Local Institution - 496

Rosario, Argentina

Local Institution - 497

Rosario, Argentina

Local Institution - 502

Rosario, Santa Fe, Argentina

Local Institution - 492

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalCelgene

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Multicenter, Open-Label Extension Study of Ora... | EligiMed