A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
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).
Key Inclusion Criteria:
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
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
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
La Jolla, California 92037, United States
Palo Alto, California 94305, United States
Jacksonville, Florida 32207, United States
Wyomissing, Pennsylvania 19610, United States
Columbia, South Carolina 29204, United States
Summerville, South Carolina 29486, United States
Ciudad Autonoma, Buenos Aires 1425, Argentina
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
Ciudad Autonoma Buenos Aires, C1128AAF, Argentina
Ciudad Autonoma de Buenos Aire, C1428DZF, Argentina
Ciudad Autonoma, C1114AHH, Argentina
Ostrava-Poruba, 70800, Czechia
Prague Praha 10, 10100, Czechia
Hamburg, 20095, Germany
Kalocsa, 6300, Hungary
Bologna, 40138, Italy
Iizuka-shi, 820-8505, Japan
Iruma-gun, 350-0495, Japan
Kitakyushu-shi, 807-8556, Japan
Kurume-shi, 839-0863, Japan
Miyagi-gun, 981-0112, Japan
Sanuki-shi, 769-2393, Japan
Sasebo-shi, 857-1195, Japan
Sayama-shi, 350-1305, Japan
Suita-shi, 565-0871, Japan
Takasaki-shi, 370-0053, Japan
Tomigusuku-shi, 901-0224, Japan
Bydgoszcz, 85168, Poland
Katowice, 40-282, Poland
Tomaszów Lubelski, 22-600, Poland
Bucharest, 011172, Romania
Barnaul, 656024, Russia
Chelyabinsk, 454076, Russia
Kazan', 420103, Russia
Kemerovo, 650099, Russia
Saint Petersburg, 190068, Russia
Yaroslavl, 150003, Russia
Bangkok, 10700, Thailand
Chiang Mai, 50200, Thailand
Songkhla, 90110, Thailand
Dnipro, 49074, Ukraine
Kharkiv, 61019, Ukraine
Kharkiv, 61039, Ukraine
Kharkiv, 61058, Ukraine
Kharkiv, 61124, Ukraine
Kherson, 73000, Ukraine
Kyiv, 03680, Ukraine
Kyiv, 04107, Ukraine
Lviv, 79010, Ukraine
Lviv, 79011, Ukraine
Vinnytsia, 21018, Ukraine