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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03025308




Registration number
NCT03025308
Ethics application status
Date submitted
17/01/2017
Date registered
19/01/2017
Date last updated
30/06/2020

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)

- Males and 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Bangkok
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Thailand
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Chiangmai
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Thailand
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Songkla
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Kharkiv
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Kherson
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Kyiv
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Lutsk
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Lviv
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Odesa
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Vinnytsia
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Vinnytsya
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Ukraine
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Zaporizhzhya
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Edinburgh
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Harlow
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North Shields
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Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Galapagos NV
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/show/NCT03025308
Trial related presentations / publications
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