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1304 RA patients tracked on filgotinib: will it hold up in real life?

NCT ID NCT04871919

Disease control Sponsor: Alfasigma S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows over 1300 adults with moderate to severe rheumatoid arthritis who are starting filgotinib (Jyseleca) as part of their normal care. Researchers will track how long patients stay on the drug, their pain, fatigue, and daily function over two years. The goal is to see how well the medication works and is tolerated outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
filgotinib (Jyseleca)
What this could lead to
If successful, this study could confirm that filgotinib works well and is safe for managing rheumatoid arthritis in everyday practice, helping doctors make better treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It does not test a new treatment, only monitors existing use, so no major breakthroughs are expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,304 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • A.O.U. Policlinico di Bari

    Bari, 70124, Italy

  • A.O.U. di Ferrara - Nuovo ospedale S.Anna

    Ferrara, 44124, Italy

  • AOU Policlinico Vittorio Emanuele-PO San Marco

    Catania, 95121, Italy

  • ASST Gaetano Pini CTO

    Milan, 20122, Italy

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • AZ Sint-Jan Brugge-Oostende

    Bruges, 8000, Belgium

  • Aberdeen Royal Infirmary PPDS

    Aberdeen, AB25 2ZA, United Kingdom

  • Algemeen Stedelijk Ziekenhuis

    Aalst, 9300, Belgium

  • Azienda Osp. Univ. Luigi Vanvitelli

    Naples, 80100, Italy

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126, Italy

  • C.H. Regional Reina Sofia

    Córdoba, 14004, Spain

  • CHU UCL Namur asbl - Site Godinne

    Yvoir, 5530, Belgium

  • CHU de Liège

    Liège, 4000, Belgium

  • Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie

    Berlin, 10117, Germany

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complexo Hospitalario Universitario

    A Coruña, 15006, Spain

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LT, United Kingdom

  • Elkerliek Ziekenhuis

    Helmond, 5707 HA, Netherlands

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Freeman Hospital

    Newcastle, NE1 4LP, United Kingdom

  • Grand Hôpital de Charleroi asbl

    Charleroi, 6000, Belgium

  • Guy's and St Thomas NHS Foundation Trust - Guy's Hospital

    London, SE5 9RS, United Kingdom

  • Hagaziekenhuis

    The Hague, 2545 AA, Netherlands

  • Hospital Clinico Universitario

    Santiago de Compostela, 15706, Spain

  • Hospital Provincial de Pontevedra

    Pontevedra, 36001, Spain

  • Hospital Universitari Son Espases

    Palma, 07120, Spain

  • Hospital Universitario Hospiten Rambla de Tenerife

    Santa Cruz de Tenerife, 38003, Spain

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 8025, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de La Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013, Spain

  • Hospital de Mérida

    Mérida, 06800, Spain

  • Hospital del Mar

    Barcelona, 8003, Spain

  • Hôpital Erasme

    Brussels, 1070, Belgium

  • Imelda VZW

    Bonheiden, 2820, Belgium

  • Internistisch-Rheumatologische Arztpraxis

    Halle, 06128, Germany

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin

    Demmin, 17109, Germany

  • Klinikverbund St. Antonius und St. Josef GmbH

    Wuppertal, 42283, Germany

  • Krankenhaus der Barmherzigen Brüder

    Trier, 54292, Germany

  • Luton and Dunstable Hospital

    Luton, LU4 0DZ, United Kingdom

  • MVZ Ambulantes Rheumazentrum Erfurt

    Erfurt, 99096, Germany

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD, Netherlands

  • Medisch Spectrum Twente

    Enschede, 7512 KZ, Netherlands

  • Medizinischen Versorgungszentrums für Rheumatologie

    Planegg, 82152, Germany

  • Ninewells Hospital - PPDS

    Dundee, DD1 95Y, United Kingdom

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD, Netherlands

  • Policlinico Gemelli

    Roma, 00168, Italy

  • Policlinico Umberto I Univ. Sapienza

    Roma, 00161, Italy

  • Praxis Dilltal

    Ehringshausen, 35630, Germany

  • Praxis far Rheumatologie, Gastroenterologie und Innere Medizin

    München, 80639, Germany

  • Praxis für Internistische Rheumatologie

    Leipzig, 04129, Germany

  • Praxis für Rheumatologie

    Hamburg, 2291, Germany

  • Praxis für Rheumatologie - Amberg

    Amberg, 92224, Germany

  • READE

    Amsterdam, 1054 HW, Netherlands

  • Reuma Instituut

    Hasselt, 3500, Belgium

  • Reumacentrum Genk

    Genk, 3600, Belgium

  • Reumaclinic Genk

    Genk, 3600, Belgium

  • Reumazorg Zuid West

    Goes, 4462 EV, Netherlands

  • Rheumahaus - GbR

    Potsdam, 14469, Germany

  • Rheumapraxis

    Leipzig, 04109, Germany

  • Rheumapraxis

    Mansfeld, 6343, Germany

  • Rheumapraxis

    Neubrandenburg, 17033, Germany

  • Rheumapraxis Mexikoplatz

    Berlin, 14163, Germany

  • Rheumapraxis am Schlachtensee

    Berlin, 14129, Germany

  • Rheumatologie im Struenseehaus

    Hamburg, 22767, Germany

  • Rheumatologisch-immunologische Arztpraxis

    Templin, 17268, Germany

  • Rheumatologische Facharztpraxis

    Magdeburg, 39104, Germany

  • Rheumatologische Schwerpunktpraxis

    Berlin, 12161, Germany

  • Rheumatologisches MVZ Dresden

    Dresden, 01109, Germany

  • Rheumatologisches Praxiszentrum St. Bonifatius

    München, 81541, Germany

  • Rheumatology Center Prof. Neeck

    Bad Doberan, 18209, Germany

  • Rheumazentrum Kupka

    Altenburg, 4600, Germany

  • Rheumazentrum Ratingen

    Ratingen, 40878, Germany

  • Rheumazentrum Ruhrgebiet

    Herne, 44649, Germany

  • Royal Berkshire Hospital NHS Foundation Trust

    Reading, RG1 5AN, United Kingdom

  • Royal Free NHS Foundation Trust

    Barnet, EN5 3DJ, United Kingdom

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP, United Kingdom

  • S.C. Reumatologia Asl3

    Genova, 16125, Italy

  • Sint Maartenskliniek

    Ubbergen, 6574 NA, Netherlands

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225, Germany

  • University Hospital Coventry

    Coventry, CV2 2DX, United Kingdom

  • Universitätsmedizin Greifswald, Abteilung Innere Medizin A

    Greifswald, 17475, Germany

  • Western General Hospital Edinburgh - PPDS

    Edinburgh, EH4 2XU, United Kingdom

  • York Teaching Hospitals NHS Foundation Trust

    York, YO31 8HE, United Kingdom

  • ZNA Jan Palfijn

    Merksem, 2170, Belgium

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