Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment (FINCH 2)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02873936

GS-US-417-0302

2016-000569-21 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

Enrollment: 449 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 for RA), 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 screening and Day 1
• Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
• Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance

Key Exclusion Criteria:

• Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol Inclusion/ Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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449 participants in 3 patient groups, including a placebo group

Filgotinib 200 mg

Experimental group

Description:

Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)

Treatment:

Drug: csDMARDs

Drug: Filgotinib

Drug: Placebo to match filgotinib

Filgotinib 100 mg

Experimental group

Description:

Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)

Treatment:

Drug: csDMARDs

Drug: Filgotinib

Drug: Placebo to match filgotinib

Placebo

Placebo Comparator group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)

Treatment:

Drug: csDMARDs

Drug: Placebo to match filgotinib