What side effects are associated with this type of intervention?

Janus Kinase (JAK) inhibitors, including tofacitinib, baricitinib, and upadacitinib, are commonly used in the treatment of Rheumatoid Arthritis. Known side effects of these medications include an increased risk of serious infections, such as tuberculosis, and other opportunistic infections. They also carry a risk of malignancies, major adverse cardiovascular events, venous thrombosis, and pulmonary embolism. Additionally, patients may experience elevated liver enzymes, lipid abnormalities, and gastrointestinal perforations. Due to these potential risks, careful monitoring and consideration of patient history are essential when using JAK inhibitors.

What prior FDA approvals exist?

Several Janus Kinase (JAK) inhibitors have been approved by the FDA for the treatment of rheumatoid arthritis. These include Tofacitinib, which was one of the first JAK inhibitors approved for RA, followed by Baricitinib and Upadacitinib. These drugs work by inhibiting the JAK-STAT signaling pathway, which is involved in the inflammatory process of RA. Filgotinib, another JAK inhibitor, is currently being studied for its long-term safety and efficacy in RA treatment.

What other types of research exist?

Promising novel alternatives to Filgotinib for RA patients include Upadacitinib and Tofacitinib, both of which are JAK inhibitors with demonstrated efficacy in clinical trials. Additionally, investigational agents like Ritlecitinib and Brepocitinib are showing potential in ongoing studies. These alternatives offer new options for patients seeking effective RA treatments.

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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 Alfasigma S.p.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 5 years

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

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.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936

Nasopharyngitis

Upper respiratory tract infection

Headache

Nausea

Bronchitis

Gallbladder empyema

Anaemia

Myocardial ischaemia

Abscess oral

Vulval abscess

Lumbar spinal stenosis

Osteitis

Depression

Rheumatoid arthritis

100%

80%

60%

40%

20%

Study treatment Arm

Filgotinib 100 mg

Placebo

Filgotinib 200 mg

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Rheumatoid Arthritis (RA) include Disease-Modifying Antirheumatic Drugs (DMARDs) like methotrexate, biologic agents such as TNF inhibitors, and Janus Kinase (JAK) inhibitors like Filgotinib. Methotrexate works by inhibiting the metabolism of folic acid, reducing inflammation. TNF inhibitors block the tumor necrosis factor, a substance involved in systemic inflammation. JAK inhibitors, including Filgotinib, target the Janus kinase pathways, which are crucial for the signaling of various inflammatory cytokines. Understanding these mechanisms helps RA patients and their doctors choose the most effective treatment tailored to their specific disease activity and progression, potentially improving outcomes and reducing side effects.