Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy (FINCH 3)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: MTX; Drug: Placebo to match MTX

Study type: Interventional

Funder types: Industry

Identifiers

NCT02886728

GS-US-417-0303

2016-000570-37 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).

Enrollment: 1,252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria) and are ACR functional class I-III.
• Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
• Limited or no prior treatment with MTX

Key Exclusion Criteria:

• Previous treatment with any janus kinase (JAK) inhibitor
• Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine
• Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,252 participants in 4 patient groups

Filgotinib 200 mg + MTX

Experimental group

Description:

Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib

Drug: Filgotinib

Filgotinib 100 mg + MTX

Experimental group

Description:

Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib

Drug: Filgotinib

Filgotinib 200 mg Monotherapy

Experimental group

Description:

Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX

Treatment:

Drug: Placebo to match filgotinib

Drug: Placebo to match MTX

Drug: Filgotinib

MTX Monotherapy

Active Comparator group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib