A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT03025308Tipo: INTERVENTIONALInicio: 28 de feb de 2017Fin estimado: 16 de may de 2025

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:
Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug
OR
Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)
Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception

Criterios de exclusión

Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
Known hypersensitivity to the study drug or its excipients
Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator

Intervenciones

drug

Filgotinib

Tablet(s) administered orally once daily

drug

Placebo to match filgotinib

Tablet(s) administered orally once daily

Ubicaciones

Ceim Investigaciones Medicas Srl

Ciudad Autonoma, Buenos Aires, Argentina

CIMEL

Buenos Aires, Argentina

Onganizacion Medica de Investigacion S.A (OMI)

Ciudad Autonoma Buenos Aires, Argentina

Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, Argentina

Consultorios Reumatológicos Pampa

Ciudad Autonoma de Buenos Aire, Argentina

Investigaciones Reumatologicas Y Osteologicas (IRO) SRL

Ciudad Autonoma, Argentina

Instituto De Reumatologia

Mendoza, Argentina

Instituto Médico Cer

Quilmes, Argentina

Instituto Iari

San Isidro, Argentina

Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

Centro Medico Privado de Reumatología

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalAlfasigma S.p.A.

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.

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