A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
Overview
- Phase
- Phase 3
- Intervention
- Filgotinib
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Alfasigma S.p.A.
- Enrollment
- 2731
- Locations
- 341
- Primary Endpoint
- Proportion of Participants Experiencing Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Intervention: Filgotinib
Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Intervention: Placebo to match filgotinib
Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Intervention: Filgotinib
Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Intervention: Placebo to match filgotinib
Open Label Phase: Filgotinib 200 mg
Filgotinib 200 mg for up to 6 years
Intervention: Filgotinib
Open Label Phase: Filgotinib 100 mg
Filgotinib 100 mg for up to 6 years
Intervention: Filgotinib
Outcomes
Primary Outcomes
Proportion of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to 6 years
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
Time Frame: Up to 6 years
Secondary Outcomes
- Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm(Up to 6 years)