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Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis (FILOSOPHY)

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ClinicalTrials.gov Identifier: NCT04871919
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Filgotinib

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Filgotinib
Individuals will receive treatment for moderate to severe active rheumatoid arthritis with at least one dose of filgotinib in accordance with the product label
Drug: Filgotinib
Tablets are administered in accordance with the product label
Other Name: Jyseleca




Primary Outcome Measures :
  1. Treatment persistence rates [ Time Frame: 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.


Secondary Outcome Measures :
  1. patients' assessment of pain, Visual Analogue Scale (Pain VAS) [ Time Frame: Up to 24 months ]
  2. patients' assessment of fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F score) [ Time Frame: Up to 24 months ]
  3. patients' assessment of Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) [ Time Frame: Up to 24 months ]
  4. medication adherence, compliance questionnaire rheumatology 19 (CQR19) [ Time Frame: Up to 24 months ]
  5. Number of adverse events and serious adverse events [ Time Frame: Up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871919


Contacts
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Contact: Galapagos Medical Information +3215342900 medicalinfo@glpg.com

Locations
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Germany
Rheumazentrum Kupka Recruiting
Altenburg, Germany, 4600
Praxis für Rheumatologie - Amberg Recruiting
Amberg, Germany, 92224
Rheumatology Center Prof. Neeck Recruiting
Bad Doberan, Germany, 18209
Fachklinik Bad Pyrmont Rheumazentrum Recruiting
Bad Pyrmont, Germany, 31812
Rheumatologische Schwerpunktpraxis Recruiting
Berlin, Germany, 12161
Rheumatologische Praxis Recruiting
Braunschweig, Germany, 38100
Praxis Dilltal Recruiting
Ehringshausen, Germany, 35630
MVZ Ambulantes Rheumazentrum Erfurt Recruiting
Erfurt, Germany, 99096
Rheumazentrum Ruhrgebiet Recruiting
Herne, Germany, 44649
Praxis für Internistische Rheumatologie Recruiting
Leipzig, Germany, 04129
Fachpraxis für Rheumatologie und Osteologie Recruiting
Nienburg, Germany, 31582
Medizinischen Versorgungszentrums für Rheumatologie Recruiting
Planegg, Germany, 82152
Rheumahaus - GbR Recruiting
Potsdam, Germany, 14469
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Galapagos Study Director Galapagos NV
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT04871919    
Other Study ID Numbers: GLPG0634-CL-401
EUPAS39767 ( Registry Identifier: EU PAS Register )
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Galapagos NV:
filgotinib
safety
effectiveness
patient reported outcome
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases