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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Filgotinib; Drug: Placebo to match filgotinib

• Registration Number: NCT03025308
• Lead Sponsor: Alfasigma S.p.A.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Study Start: 2017-02-28
• Primary Completion: 2025-05-16
• Study Completion: 2025-05-16
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2731

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blinded Phase: Filgotinib 200 mg	Placebo to match filgotinib	Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Open Label Phase: Filgotinib 200 mg	Filgotinib	Filgotinib 200 mg for up to 6 years
Blinded Phase: Filgotinib 100 mg	Filgotinib	Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Blinded Phase: Filgotinib 100 mg	Placebo to match filgotinib	Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Open Label Phase: Filgotinib 100 mg	Filgotinib	Filgotinib 100 mg for up to 6 years
Blinded Phase: Filgotinib 200 mg	Filgotinib	Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Experiencing Adverse Events (AEs)	Up to 6 years
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities	Up to 6 years

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm	Up to 6 years

Trial Locations

Locations (341)

Rheumatology Associates of North Alabama, PC; 🇺🇸 Huntsville, Alabama, United States

Arthrocare, Arthritis Care & Research PC; 🇺🇸 Gilbert, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.; 🇺🇸 Tucson, Arizona, United States

Medvin Clinical Research; 🇺🇸 Whittier, California, United States

C.V. Mehta M.D. Medical Corporation; 🇺🇸 Hemet, California, United States

University of California San Diego (UCSD) - Perlman Ambulatory Clinic; 🇺🇸 La Jolla, California, United States

Keck Medicine of USC- Division of Rheumatology; 🇺🇸 Los Angeles, California, United States

Desert Medical Advances; 🇺🇸 Palm Desert, California, United States

Stanford University Hospitals and Clinics (Immunology & Rheumatology); 🇺🇸 Palo Alto, California, United States

C.V. Mehta Medical Corporation; 🇺🇸 Riverside, California, United States

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