Clinical trial NCT04871919: Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
Official title: A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: filgotinib
safety
effectiveness
patient reported outcome
Lead sponsor: Alfasigma S.p.A.
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 1304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients aged ≥ 18 years with moderate to severe active RA receiving filgotinib who will be enrolled across participating countries within Europe.

Brief 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 criteria: 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 outcomes:
measure: Treatment persistence rates
timeFrame: Up to 24 months
Secondary outcomes:
measure: patients' assessment of pain, Visual Analogue Scale (Pain VAS)
timeFrame: Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.
measure: patients' assessment of fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F score)
timeFrame: Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.
measure: patients' assessment of Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA)
timeFrame: Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.
measure: medication adherence, compliance questionnaire rheumatology 19 (CQR19)
timeFrame: Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.
measure: medication adherence, compliance questionnaire rheumatology 5 (CQR5)
timeFrame: Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.
measure: Number of adverse events and serious adverse events
timeFrame: Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.
measure: patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID)
timeFrame: Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda VZW
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussel
country: Belgium
facility: Hôpital Erasme
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi asbl
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Genk
country: Belgium
facility: Reumacentrum Genk
city: Genk
country: Belgium
facility: Reumaclinic Genk
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Reuma Instituut
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Yvoir
country: Belgium
facility: CHU UCL Namur asbl - Site Godinne
city: Altenburg
country: Germany
facility: Rheumazentrum Kupka
city: Amberg
country: Germany
facility: Praxis für Rheumatologie - Amberg
city: Bad Doberan
country: Germany
facility: Rheumatology Center Prof. Neeck
city: Berlin
country: Germany
facility: Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Berlin
country: Germany
facility: Rheumapraxis am Schlachtensee
city: Berlin
country: Germany
facility: Rheumapraxis Mexikoplatz
city: Demmin
country: Germany
facility: Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin
city: Dresden
country: Germany
facility: Rheumatologisches MVZ Dresden
city: Düsseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Ehringshausen
country: Germany
facility: Praxis Dilltal
city: Erfurt
country: Germany
facility: MVZ Ambulantes Rheumazentrum Erfurt
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald, Abteilung Innere Medizin A
city: Halle
country: Germany
facility: Internistisch-Rheumatologische Arztpraxis
city: Hamburg
country: Germany
facility: Rheumatologie im Struenseehaus
city: Hamburg
country: Germany
facility: Praxis für Rheumatologie
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Leipzig
country: Germany
facility: Rheumapraxis
city: Leipzig
country: Germany
facility: Praxis für Internistische Rheumatologie
city: Magdeburg
country: Germany
facility: Rheumatologische Facharztpraxis
city: Mansfeld
country: Germany
facility: Rheumapraxis
city: München
country: Germany
facility: Praxis far Rheumatologie, Gastroenterologie und Innere Medizin
city: München
country: Germany
facility: Rheumatologisches Praxiszentrum St. Bonifatius
city: Neubrandenburg
country: Germany
facility: Rheumapraxis
city: Planegg
country: Germany
facility: Medizinischen Versorgungszentrums für Rheumatologie
city: Potsdam
country: Germany
facility: Rheumahaus - GbR
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Templin
country: Germany
facility: Rheumatologisch-immunologische Arztpraxis
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Wuppertal
country: Germany
facility: Klinikverbund St. Antonius und St. Josef GmbH
city: Bari
country: Italy
facility: A.O.U. Policlinico di Bari
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele-PO San Marco
city: Ferrara
country: Italy
facility: A.O.U. di Ferrara - Nuovo ospedale S.Anna
city: Genova
country: Italy
facility: S.C. Reumatologia Asl3
city: Milano
country: Italy
facility: ASST Gaetano Pini CTO
city: Napoli
country: Italy
facility: Azienda Osp. Univ. Luigi Vanvitelli
city: Roma
country: Italy
facility: Policlinico Umberto I Univ. Sapienza
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Di Verona
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amsterdam
country: Netherlands
facility: READE
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Goes
country: Netherlands
facility: Reumazorg Zuid West
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón
city: Córdoba
country: Spain
facility: C.H. Regional Reina Sofia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
city: Mérida
country: Spain
facility: Hospital de Mérida
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
city: Pontevedra
country: Spain
facility: Hospital Provincial de Pontevedra
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Hospiten Rambla de Tenerife
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary PPDS
city: Barnet
country: United Kingdom
facility: Royal Free NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: Dundee
country: United Kingdom
facility: Ninewells Hospital - PPDS
city: Edinburgh
country: United Kingdom
facility: Western General Hospital Edinburgh - PPDS
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Foundation Trust - Guy's Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital NHS Foundation Trust
city: York
country: United Kingdom
facility: York Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Alfasigma S.p.A.
name: Alfasigma Study Director
role: STUDY_DIRECTOR
References: