Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis (FINCH 4)
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ClinicalTrials.gov Identifier: NCT03025308 |
Recruitment Status :
Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : October 21, 2022
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Sponsor:
Galapagos NV
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Galapagos NV
Tracking Information | |||||
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First Submitted Date ICMJE | January 17, 2017 | ||||
First Posted Date ICMJE | January 19, 2017 | ||||
Last Update Posted Date | October 21, 2022 | ||||
Actual Study Start Date ICMJE | February 28, 2017 | ||||
Estimated Primary Completion Date | April 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [ Time Frame: Up to 6 years ] | ||||
Original Secondary Outcome Measures ICMJE |
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [ Time Frame: Up to 3 years ] | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis | ||||
Official Title ICMJE | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis | ||||
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). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Masking Description: This study was originally designed and initiated as a double-blind study but the study design will change to open-label following implementation of the protocol amendment # 4. Primary Purpose: Treatment
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Condition ICMJE | Rheumatoid Arthritis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2022 Oct 7. doi: 10.1007/s40744-022-00494-1. Online ahead of print. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
2731 | ||||
Original Estimated Enrollment ICMJE |
2800 | ||||
Estimated Study Completion Date ICMJE | May 2025 | ||||
Estimated Primary Completion Date | April 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | Netherlands | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT03025308 | ||||
Other Study ID Numbers ICMJE | GS-US-417-0304 2016-003630-25 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Galapagos NV | ||||
Original Responsible Party | Gilead Sciences | ||||
Current Study Sponsor ICMJE | Galapagos NV | ||||
Original Study Sponsor ICMJE | Gilead Sciences | ||||
Collaborators ICMJE | Gilead Sciences | ||||
Investigators ICMJE |
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PRS Account | Galapagos NV | ||||
Verification Date | October 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |