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

Phase 3 Completed NCT03025308

Condition	Rheumatoid Arthritis
Phase	Phase 3
Sponsor	Alfasigma S.p.A.
Status	Completed
Enrollment	2,731 participants
Interventions	Filgotinib, Placebo to match filgotinib
Start date	Feb 28, 2017
Completion date	May 16, 2025
Results posted	Jul 27, 2026

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).

Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Day 1 to Week 376 (end of study) · Participants

Filgotinib 200 mg: With Prior Filgotinib Exposure	1071 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	300 Participants
Filgotinib 100 mg: With Prior Filgotinib Exposure	769 Participants
Filgotinib 100 mg: Without Prior Filgotinib Exposure	283 Participants
Filgotinib 200 mg: With Prior Filgotinib Exposure	288 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	74 Participants

Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Serum Chemistry Parameters

Day 1 to Week 376 (end of study) · Participants

Filgotinib 200 mg: With Prior Filgotinib Exposure	394 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	98 Participants
Filgotinib 100 mg: With Prior Filgotinib Exposure	274 Participants
Filgotinib 100 mg: Without Prior Filgotinib Exposure	106 Participants
Filgotinib 200 mg: With Prior Filgotinib Exposure	49 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	16 Participants

Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Hematology Parameters

Day 1 to Week 376 (end of study) · Participants

Filgotinib 200 mg: With Prior Filgotinib Exposure	247 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	60 Participants
Filgotinib 100 mg: With Prior Filgotinib Exposure	165 Participants
Filgotinib 100 mg: Without Prior Filgotinib Exposure	60 Participants
Filgotinib 200 mg: With Prior Filgotinib Exposure	86 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	29 Participants

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

Dietary Salt in Rheumatoid Arthritis — Vanderbilt University Medical Center
Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life) — University of North Carolina, Chapel Hill
CD40L Antagonism in Rheumatoid Arthritis (RA) — National Institute of Allergy and Infectious Diseases (NIAID)
A Study of Baricitinib in Participants With Rheumatoid Arthritis — Eli Lilly and Company
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis — Eli Lilly and Company
Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replace — Smith & Nephew, Inc.

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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