Physician Research Collaboration, LLC | Lincoln, NE
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About
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).
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
2,731 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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