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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
Secondary ID [1] 0 0
2016-003630-25
Secondary ID [2] 0 0
GS-US-417-0304
Universal Trial Number (UTN)
Trial acronym
FINCH 4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Up to 6 years
Primary outcome [2] 0 0
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
Timepoint [2] 0 0
Up to 6 years
Secondary outcome [1] 0 0
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm
Timepoint [1] 0 0
Up to 6 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
Accrual to date
Final
2731
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [2] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment hospital [3] 0 0
Southern Clinical Research Pty Ltd - Hobart
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
6100 - Victoria Park
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment outside Australia
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Niska Banja
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Bratislava
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Slovakia
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Durban
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Johannesburg
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Santiago de Compostela
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Keelung
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiangmai
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Thailand
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Songkla
Country [218] 0 0
Ukraine
State/province [218] 0 0
Dnipro
Country [219] 0 0
Ukraine
State/province [219] 0 0
Kharkiv
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Ukraine
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Kherson
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Ukraine
State/province [221] 0 0
Kyiv
Country [222] 0 0
Ukraine
State/province [222] 0 0
Lutsk
Country [223] 0 0
Ukraine
State/province [223] 0 0
Lviv
Country [224] 0 0
Ukraine
State/province [224] 0 0
Odesa
Country [225] 0 0
Ukraine
State/province [225] 0 0
Vinnytsia
Country [226] 0 0
Ukraine
State/province [226] 0 0
Vinnytsya
Country [227] 0 0
Ukraine
State/province [227] 0 0
Zaporizhzhya
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Edinburgh
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Harlow
Country [230] 0 0
United Kingdom
State/province [230] 0 0
North Shields
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galapagos NV
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03025308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Galapagos Study Director
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Gilead Sciences
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03025308