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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 October 2023
• Main ID: NCT03025308
• Date of registration: 17/01/2017
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis FINCH 4
• Scientific title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
• Date of first enrolment: February 28, 2017
• Target sample size: 2731
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03025308
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Galapagos Study Director
• Affiliation: Gilead Sciences

Key inclusion & 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

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Filgotinib

Drug: Placebo to match filgotinib

Primary Outcome(s)

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 Outcome(s)

Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [Time Frame: Up to 6 years]

Secondary ID(s)

2016-003630-25

GS-US-417-0304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences