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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03025308
Registration number
NCT03025308
Ethics application status
Date submitted
17/01/2017
Date registered
19/01/2017
Date last updated
18/10/2023
Titles & IDs
Public title
Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
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Scientific title
A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
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Secondary ID [1]
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2016-003630-25
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Secondary ID [2]
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GS-US-417-0304
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Universal Trial Number (UTN)
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Trial acronym
FINCH 4
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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0
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0
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Osteoarthritis
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Inflammatory and Immune System
0
0
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Experimental: Blinded Phase: Filgotinib 200 mg - Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Experimental: Blinded Phase: Filgotinib 100 mg - Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Experimental: Open Label Phase: Filgotinib 200 mg - Filgotinib 200 mg for up to 6 years
Experimental: Open Label Phase: Filgotinib 100 mg - Filgotinib 100 mg for up to 6 years
Treatment: Drugs: Filgotinib
Tablet(s) administered orally once daily
Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Participants Experiencing Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to 6 years
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Primary outcome [2]
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Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
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Assessment method [2]
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Timepoint [2]
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Up to 6 years
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Secondary outcome [1]
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Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm
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Assessment method [1]
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Timepoint [1]
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Up to 6 years
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/02/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
2731
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Recruitment in Australia
Recruitment state(s)
QLD,WA
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Recruitment hospital [1]
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Rheumatology Research Unit - Maroochydore
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Recruitment hospital [2]
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RK Will Pty Ltd - Victoria Park
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Recruitment hospital [3]
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Southern Clinical Research Pty Ltd - Hobart
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Recruitment postcode(s) [1]
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4558 - Maroochydore
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Recruitment postcode(s) [2]
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6100 - Victoria Park
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7000 - Hobart
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Yokohama-shi
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Timaru
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Elblag
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Gdynia
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Tomaszów Lubelski
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Torun
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Barnaul
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Russian Federation
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Belgrade
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Serbia
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Niska Banja
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Stellenbosch
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La Coruña
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Madrid
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Spain
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Valencia
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Keelung
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Taichung
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Taipei
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Songkla
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Ukraine
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Dnipro
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Ukraine
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Kharkiv
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Kyiv
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Lutsk
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Lviv
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Odesa
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Vinnytsya
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Ukraine
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Zaporizhzhya
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Edinburgh
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United Kingdom
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Harlow
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United Kingdom
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North Shields
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United Kingdom
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Warrington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Galapagos NV
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Gilead Sciences
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Address [1]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03025308
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Trial related presentations / 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. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.
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Public notes
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Contacts
Principal investigator
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Galapagos Study Director
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Gilead Sciences
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03025308
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