A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

TerminadoFase 3ClinicalTrials.gov

ID: NCT03464097Tipo: INTERVENTIONALInicio: 27 de jun de 2018Fin estimado: 3 de oct de 2024

Traducción no disponible, mostrando original

Resumen

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy 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
In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study

Criterios de exclusión

Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis

Intervenciones

drug

Ozanimod

Specified dose on specified days

other

Placebo

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

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