Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

NCT04871919 · tracked via the Priya Life Science UK tracker

Sponsor

Alfasigma S.p.A.

Phase

Observational

Started

2021-05-11

Last updated

2025-09-15

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Filgotinib

Filgotinib: Tablets are administered in accordance with the product label

Study summary

An observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (RA) receiving filgotinib in real-world setting.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients aged ≥ 18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local standard of care and product label for the first time. * Patients must be willing and able to use an electronic device to complete the study patient-reported outcome (PRO). Exclusion Criteria: \- Participation in any other interventional or non-interventional study without prior approval from the Medical Monitor. This does not preclude inclusion of patients enrolled to national registries.

Primary outcome measure(s)

Treatment persistence rates — Up to 24 months
To evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation.

Trial sites (89)

Facility	City	Region
Algemeen Stedelijk Ziekenhuis	Aalst	Belgium
Imelda VZW	Bonheiden	Belgium
AZ Sint-Jan Brugge-Oostende	Bruges	Belgium
Hôpital Erasme	Brussels	Belgium
Cliniques Universitaires Saint-Luc	Brussels	Belgium
Grand Hôpital de Charleroi asbl	Charleroi	Belgium
UZ Antwerpen	Edegem	Belgium
Reumacentrum Genk	Genk	Belgium
Reumaclinic Genk	Genk	Belgium
AZ Maria Middelares	Ghent	Belgium
Reuma Instituut	Hasselt	Belgium
UZ Leuven	Leuven	Belgium
CHU de Liège	Liège	Belgium
ZNA Jan Palfijn	Merksem	Belgium
CHU UCL Namur asbl - Site Godinne	Yvoir	Belgium
Rheumazentrum Kupka	Altenburg	Germany
Praxis für Rheumatologie - Amberg	Amberg	Germany
Rheumatology Center Prof. Neeck	Bad Doberan	Germany
Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie	Berlin	Germany
Rheumatologische Schwerpunktpraxis	Berlin	Germany
Rheumapraxis am Schlachtensee	Berlin	Germany
Rheumapraxis Mexikoplatz	Berlin	Germany
Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin	Demmin	Germany
Rheumatologisches MVZ Dresden	Dresden	Germany
Universitatsklinikum Dusseldorf	Düsseldorf	Germany
Praxis Dilltal	Ehringshausen	Germany
MVZ Ambulantes Rheumazentrum Erfurt	Erfurt	Germany
Universitätsmedizin Greifswald, Abteilung Innere Medizin A	Greifswald	Germany
Internistisch-Rheumatologische Arztpraxis	Halle	Germany
Rheumatologie im Struenseehaus	Hamburg	Germany
Praxis für Rheumatologie	Hamburg	Germany
Rheumazentrum Ruhrgebiet	Herne	Germany
Rheumapraxis	Leipzig	Germany
Praxis für Internistische Rheumatologie	Leipzig	Germany
Rheumatologische Facharztpraxis	Magdeburg	Germany
Rheumapraxis	Mansfeld	Germany
Praxis far Rheumatologie, Gastroenterologie und Innere Medizin	München	Germany
Rheumatologisches Praxiszentrum St. Bonifatius	München	Germany
Rheumapraxis	Neubrandenburg	Germany
Medizinischen Versorgungszentrums für Rheumatologie	Planegg	Germany

+ 49 more sites — see the full list on the official registry below.

More Alfasigma S.p.A. trials in the UK

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) Active, not recruiting

Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents Recruiting

OLE Study With Filgotinib in JIA Recruiting

A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis Active, not recruiting

Other trials for the same condition

Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty Recruiting

A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis Recruiting

Safety of Splenic Stimulation for RA Recruiting

A Study of AZD0120 in Autoimmune Diseases Recruiting

Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04871919 on ClinicalTrials.gov ↗ ← All trials in the UK