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Completed
NCT03025308
Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
Conditions: Rheumatoid Arthritis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 2731
Sponsor: Alfasigma S.p.A.
Location: Rheumatology Associates of North Alabama, PC Huntsville Alabama
Summary
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).
Eligibility 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
* 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
Key Exclusion Criteria:
* 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
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT03025308). StuddyBuddy aggregates publicly available trial information.