Long-Term Safety of Filgotinib for Rheumatoid Arthritis
(FINCH 4 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term safety and tolerability of a medication called filgotinib for people with rheumatoid arthritis (RA). Researchers are testing different doses to assess their effects on RA symptoms like joint pain and swelling. The trial targets individuals who have completed a previous filgotinib study and might benefit from continued treatment. Participants should have finished a prior filgotinib study and have RA not complicated by other joint diseases. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new RA treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that filgotinib is generally safe for people with rheumatoid arthritis (RA). Studies have found that it can be used safely for up to 8 years without new safety concerns. The treatment maintains a good safety record, with low rates of serious issues such as heart problems, blood clots, and cancer. Overall, based on long-term evidence, filgotinib appears to be a safe choice for those with RA.12345
Why do researchers think this study treatment might be promising for rheumatoid arthritis?
Filgotinib is unique because it targets the Janus kinase 1 (JAK1) enzyme, which plays a key role in the inflammation process associated with rheumatoid arthritis. This selective targeting is believed to offer a more precise approach, potentially reducing inflammation with fewer side effects compared to non-selective JAK inhibitors like tofacitinib or baricitinib, which affect multiple JAK enzymes. Researchers are excited about filgotinib because it offers the possibility of long-term safety and efficacy in managing rheumatoid arthritis symptoms, potentially providing relief for patients who don't respond well to existing treatments like methotrexate or biologics. Plus, with varying doses of 100 mg and 200 mg being explored, it offers flexibility in treatment options tailored to patient needs.
What is the effectiveness track record for filgotinib in treating rheumatoid arthritis?
Research has shown that filgotinib effectively treats rheumatoid arthritis (RA). One study found that by week 156, 18.8% of patients taking 200 mg and 15.4% taking 100 mg of filgotinib experienced remission, meaning they had no disease symptoms. In this trial, participants will receive either 100 mg or 200 mg of filgotinib. Filgotinib is generally well tolerated, allowing most people to take it without serious side effects for up to 8 years. Patients have experienced more symptom improvement compared to those taking a placebo, which contains no active medicine. Overall, evidence supports filgotinib's ability to reduce RA symptoms and improve quality of life.678910
Who Is on the Research Team?
Alfasigma Study Director
Principal Investigator
Alfasigma S.p.A.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Blinded Phase
Participants receive either Filgotinib 100 mg or 200 mg with placebo for up to 6 years
Open Label Phase
Participants receive Filgotinib 100 mg or 200 mg for up to 6 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Filgotinib
- Placebo to match filgotinib
Trial Overview
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.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Filgotinib 200 mg for up to 6 years
Filgotinib 100 mg for up to 6 years
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alfasigma S.p.A.
Lead Sponsor
Galapagos NV
Lead Sponsor
Dr. Walid Abi-Saab
Galapagos NV
Chief Medical Officer since 2017
MD from the American University of Beirut, specialization in Internal Medicine and Rheumatology
Dr. Paul Stoffels
Galapagos NV
Chief Executive Officer since 2022
MD from the University of Antwerp, specialization in Infectious Diseases and Tropical Medicine at the Institute of Tropical Medicine in Antwerp
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
week 156 interim results from a long-term extension study
At week 156, Boolean remission 1.0 was achieved by 18.8% and 15.4% of patients treated with de novo filgotinib 200 mg and 100 mg, respectively, ...
Efficacy and safety of filgotinib in patients with rheumatoid ...
At week 156, Boolean remission 1.0 was achieved by 18.8% and 15.4% of patients treated with de novo filgotinib 200 mg and 100 mg, respectively, ...
Safety and efficacy of filgotinib in patients with rheumatoid ...
Filgotinib was well tolerated in patients with RA for up to 8 years. Safety and efficacy profiles were maintained in patients previously receiving either ...
Efficacy and safety of filgotinib in patients with moderately ...
Filgotinib 200 mg/100 mg elicited greater improvements in disease activity and patient-reported outcomes than placebo. Efficacy and tolerability ...
Integrated safety analysis of filgotinib in patients with ...
These results provide an update on the long-term integrated safety data from seven clinical trials over a median (maximum) treatment duration of 3.8 (8.3) ...
Safety and efficacy of filgotinib in patients with rheumatoid ...
Filgotinib was well tolerated in patients with RA for up to 8 years. Safety and efficacy profiles were maintained in patients previously receiving either ...
Integrated safety analysis of filgotinib in patients with ...
Analyses of long-term integrated safety data demonstrate that filgotinib was generally well tolerated, with no new safety findings identified in the overall RA ...
NCT03025308 | Long Term Extension Study to Assess the ...
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 ...
9.
rheumatologyadvisor.com
rheumatologyadvisor.com/news/low-cardiovascular-malignancy-risks-with-filgotinib-in-ra-uc/Filgotinib Safety Data Shows Low Cardiovascular and ...
The long-term incidence of MACE, VTE, and malignancies is low among patients with RA or UC receiving filgotinib, though a slight increase ...
Long-Term Safety, Efficacy, and Patient-Centered ...
Long-term extension study to assess the safety and efficacy of filgotinib in adults with rheumatoid arthritis (FINCH 4). NLM identifier ...
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