The trial is taking place at:
I

IRIS Research and Development | Plantation, FL

Veeva-enabled site

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

G

Galapagos

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)

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

Trial contacts and locations

345

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Data sourced from clinicaltrials.gov

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