Long-Term Safety of Filgotinib for Rheumatoid Arthritis

(FINCH 4 Trial)

Recruiting in Palo Alto (17 mi)

+345 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alfasigma S.p.A.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial aims to check the ongoing safety and tolerability of filgotinib, a medication that helps reduce inflammation and pain. The study focuses on people with rheumatoid arthritis who have already used filgotinib in a previous study. Filgotinib works by blocking enzymes that cause inflammation, helping to reduce swelling and pain. Filgotinib has been approved for the treatment of rheumatoid arthritis in adults who respond inadequately to other treatments in Europe and Japan.

Research Team

Alfasigma Study Director

Principal Investigator

Alfasigma S.p.A.

Eligibility Criteria

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

I'm sorry, I cannot provide a summary for this screening criterion as it is incomplete. Please provide more information.

OR Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status

I completed a Gilead filgotinib study for RA and may benefit from continuing it.

Exclusion Criteria

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

Known hypersensitivity to the study drug or its excipients

You have a joint disease other than rheumatoid arthritis that could be risky or affect the study results, according to the doctor's judgment.

Treatment Details

Interventions

• Filgotinib (Janus Kinase (JAK) Inhibitor)
• Placebo to match filgotinib (Drug)

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.

Participant Groups

Group I: Open Label Phase: Filgotinib 200 mg Experimental Treatment 1 Intervention

Filgotinib 200 mg for up to 6 years

Group II: Open Label Phase: Filgotinib 100 mg Experimental Treatment 1 Intervention

Filgotinib 100 mg for up to 6 years

Group III: Blinded Phase: Filgotinib 200 mg Experimental Treatment 2 Interventions

Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years

Group IV: Blinded Phase: Filgotinib 100 mg Experimental Treatment 2 Interventions

Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years

Who Is Running the Clinical Trial?

Alfasigma S.p.A.

Lead Sponsor

Trials

28

Recruited

11,500+

Galapagos NV

Lead Sponsor

Trials

140

Recruited

23,500+

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

Trials

1,150

Recruited

878,000+

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