Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

• Status: Active, not recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galapagos NV; Gilead Sciences
• Collaborators: Galapagos NV; Gilead Sciences

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)

• Males and 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.