A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

TerminadoFase 3ClinicalTrials.gov

ID: NCT02914600Tipo: INTERVENTIONALInicio: 17 de mar de 2017Fin estimado: 1 de ago de 2023

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Criterios de exclusión

Known hypersensitivity to the study drug
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
Use of prohibited concomitant medications as outlined in the study protocol

Intervenciones

drug

Filgotinib

Tablet administered orally once a day

drug

Placebo

Tablet administered orally once a day

Ubicaciones

Fundacion Estudios Clinicos CiRec

Rosario, Argentina

Patrocinadores

PrincipalGalapagos NV

ColaboradorGilead Sciences

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 Long-Term Extension Study to Evaluate the Safety of Fil... | EligiMed