Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (FINCH 1)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02889796

GS-US-417-0301

2016-000568-41 (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: 1,759 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Have a diagnosis of rheumatoid arthritis (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.
• Ongoing treatment with a stable dose of MTX

Key Exclusion Criteria:

• Previous treatment with any janus kinase (JAK) inhibitor

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,759 participants in 6 patient groups, including a placebo group

Filgotinib 200 mg

Experimental group

Description:

Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib

Drug: Filgotinib

Drug: Placebo to match adalimumab

Filgotinib 100 mg

Experimental group

Description:

Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib

Drug: Filgotinib

Drug: Placebo to match adalimumab

Adalimumab

Active Comparator group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX

Treatment:

Drug: MTX

Drug: Adalimumab

Drug: Placebo to match filgotinib

Placebo to Filgotinib 200 mg

Experimental group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib

Drug: Filgotinib

Drug: Placebo to match adalimumab

Placebo to Filgotinib 100 mg

Experimental group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib

Drug: Filgotinib

Drug: Placebo to match adalimumab

Placebo Never Received Filgotinib

Placebo Comparator group

Description:

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.

Treatment:

Drug: MTX

Drug: Placebo to match filgotinib

Drug: Placebo to match adalimumab