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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
30/10/2024

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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Taoyuan
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Chiangmai
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Songkla
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Ukraine
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Kharkiv
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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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North Shields
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United Kingdom
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Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alfasigma S.p.A.
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alfasigma Study Director
Address 0 0
Alfasigma S.p.A.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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