Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis (FINCH 4)

Alfasigma

Status and phase: Active, not recruiting; Phase 3

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03025308

2016-003630-25 (EudraCT Number)

GS-US-417-0304

Details and patient eligibility

About

The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

Enrollment: 2,731 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:

  • Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug

    • OR

  • Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status

• Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)

• Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception

Key Exclusion Criteria:

• Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
• Known hypersensitivity to the study drug or its excipients
• Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,731 participants in 4 patient groups

Blinded Phase: Filgotinib 200 mg

Experimental group

Description:

Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years

Treatment:

Drug: Placebo to match filgotinib

Drug: Filgotinib

Blinded Phase: Filgotinib 100 mg

Experimental group

Description:

Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years

Treatment:

Drug: Placebo to match filgotinib

Drug: Filgotinib

Open Label Phase: Filgotinib 200 mg

Experimental group

Description:

Filgotinib 200 mg for up to 6 years

Treatment:

Drug: Filgotinib

Open Label Phase: Filgotinib 100 mg

Experimental group

Description:

Filgotinib 100 mg for up to 6 years

Treatment:

Drug: Filgotinib