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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03025308). StuddyBuddy aggregates publicly available trial information.