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Janus Kinase (JAK) Inhibitor

Long-Term Safety of Filgotinib for Rheumatoid Arthritis (FINCH 4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Galapagos NV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
OR
Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

FINCH 4 Trial Summary

This trial will study the long-term safety of the drug filgotinib in people who have completed other trials testing the drug's effectiveness in treating rheumatoid arthritis.

Who is the study for?
This trial is for adults with rheumatoid arthritis who completed a prior filgotinib study. They must be able to use approved contraception if of childbearing potential and have a negative pregnancy test before starting the extension study. Those with other autoimmune diseases, known hypersensitivity to filgotinib or its components, or any condition that risks participation are excluded.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of Filgotinib in those who've previously taken it for rheumatoid arthritis. Participants will either continue with Filgotinib or receive a placebo designed to look like Filgotinib.See study design
What are the potential side effects?
Possible side effects of Filgotinib may include infections, headaches, nausea, digestive issues, and abnormal blood tests results. The exact side effects can vary from person to person.

FINCH 4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
This criterion does not apply to me.
Select...
I am a woman who can have children and I have a negative pregnancy test before starting the study drug.

FINCH 4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Experiencing Adverse Events (AEs)
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
Secondary outcome measures
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936
6%
Nasopharyngitis
6%
Headache
6%
Upper respiratory tract infection
5%
Nausea
2%
Bronchitis
1%
Lumbar spinal stenosis
1%
Abscess oral
1%
Osteitis
1%
Rheumatoid arthritis
1%
Gallbladder empyema
1%
Depression
1%
Myocardial ischaemia
1%
Anaemia
1%
Vulval abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
Filgotinib 100 mg
Placebo
Filgotinib 200 mg

FINCH 4 Trial Design

4Treatment groups
Experimental Treatment
Group I: Open Label Phase: Filgotinib 200 mgExperimental Treatment1 Intervention
Filgotinib 200 mg for up to 6 years
Group II: Open Label Phase: Filgotinib 100 mgExperimental Treatment1 Intervention
Filgotinib 100 mg for up to 6 years
Group III: Blinded Phase: Filgotinib 200 mgExperimental Treatment2 Interventions
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Group IV: Blinded Phase: Filgotinib 100 mgExperimental Treatment2 Interventions
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgotinib
FDA approved
Placebo to match filgotinib
2016
Completed Phase 3
~3600

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
840,110 Total Patients Enrolled
15 Trials studying Rheumatoid Arthritis
4,982 Patients Enrolled for Rheumatoid Arthritis
Galapagos NVLead Sponsor
137 Previous Clinical Trials
20,192 Total Patients Enrolled
18 Trials studying Rheumatoid Arthritis
7,236 Patients Enrolled for Rheumatoid Arthritis
Galapagos Study DirectorStudy DirectorGilead Sciences
21 Previous Clinical Trials
10,395 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
3,384 Patients Enrolled for Rheumatoid Arthritis

Media Library

Filgotinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03025308 — Phase 3
Rheumatoid Arthritis Research Study Groups: Blinded Phase: Filgotinib 100 mg, Open Label Phase: Filgotinib 200 mg, Open Label Phase: Filgotinib 100 mg, Blinded Phase: Filgotinib 200 mg
Rheumatoid Arthritis Clinical Trial 2023: Filgotinib Highlights & Side Effects. Trial Name: NCT03025308 — Phase 3
Filgotinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03025308 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential Filgotinib side effects for consumers?

"Filgotinib's efficacy is supported by some data, and it has received multiple rounds of safety testing, so we've given it a 3."

Answered by AI

Are people currently being signed up for this clinical trial?

"Currently, this clinical trial is not enrolling patients. However, it was updated as recently as October 20th, 2022. For those looking for other studies, there are 399 trials for rheumatoid arthritis and 9 Filgotinib trials that are currently recruiting patients."

Answered by AI

Did prior research focus on Filgotinib's effects?

"The first study of filgotinib was completed in 2014 at Clinica de Especialidades Medicas. As of right now, there have been a total of 14 studies with 9 more currently underway. The locations for these active studies are primarily in San Antonio, Texas."

Answered by AI

To the best of your knowledge, does a study like this exist?

"Gilead Sciences sponsored the first Filgotinib trial in 2014. Since then, this medication has undergone 9 clinical trials spanning 50 different countries and 202 cities."

Answered by AI

Are there many medical facilities participating in this research project within the city limits?

"In total, 74 clinics are running this trial; a few examples include Arthritis & Osteoporosis Center of South Texas in San Antonio, Trinity Universal Research Associates, Inc in Plano, and Omega Research Consultants LLC in Orlando."

Answered by AI

How many individuals are being monitored in this experiment?

"This study is not recruiting participants at the moment, as shown by its clinical trial post from February 28th, 2017 that was last edited on October 20th, 2022. However, there are 399 other trials for rheumatoid arthritis and 9 studies specifically for Filgotinib that are actively admitting patients."

Answered by AI

Who else is applying?

What state do they live in?
California
Oklahoma
Missouri
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Kansas Medical Center
Clayton Medical Research, P.C.
Arthritis Group, PC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

TRYING TO GET HELP WITH MY KNEES, WOULD LOVE TO TRY THIS STUDY.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
2017. "Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03025308.
All > Rheumatoid Arthritis > Ra
~310 spots leftby Apr 2025
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