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

Palo Alto (17 mi)

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.

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

This criterion does not apply to me.

I am a woman who can have children and I have a negative pregnancy test before starting the study drug.

Treatment Details

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.

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