An Observational Study to Assess the Real-World Effectiveness of Upadacitinib in Adult Participants With Rheumatoid Arthritis
NCT ID: NCT05170646
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
97 participants
OBSERVATIONAL
2022-03-14
2024-01-31
Brief Summary
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Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. Adult participants with moderate-to-severe RA will be enrolled. Around 150 participants will be enrolled in the study in multiple sites in the United Kingdom.
Participants will receive upadacitinib per their physician's usual prescription. Individual data will be collected for 6 months.
No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants treated with upadacitinib
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Moderate RA (defined by National Institute for Health and Care Excellence \[NICE\] as 28-joint Disease Activity Score \[DAS28\] C-reactive protein \[CRP\] \>3.2 and ≤5.1) or severe RA (defined by NICE as DAS28 CRP \>5.1) at the time of enrollment.
* Prescribed upadacitinib in line with marketing authorization.
* Decision to treat with upadacitinib has been made independently and prior to enrolment in the study.
* Able to read and understand English.
* Willing and able to participate in the collection of patient-reported data via mobile app.
Exclusion Criteria
* Previously received \>4 biologic disease-modifying antirheumatic drugs (bDMARD) (1 switch to a biosimilar for non-clinical reasons is allowed for each bDMARD received) or any Janus kinase (JAK) inhibitor for the treatment of RA.
* In the opinion of the treating clinician, participant symptoms are predominately being driven by fibromyalgia or unrelated pain component instead of underlying inflammatory disease.
* Participation in any interventional clinical trial within the 3 months prior to initiation or at any point during the study observation period.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University Hospitals of Morecambe Bay NHS Foundation Trust /ID# 242376
Kendal, Cumbria, United Kingdom
Leicester Royal Infirmary /ID# 244674
Leicester, England, United Kingdom
Medway NHS Foundation Trust /ID# 244673
Gillingham, Kent, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 251704
London, London, City of, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 251700
Norwich, Norfolk, United Kingdom
Northampton General Hospital NHS Trust /ID# 251710
Northampton, Northamptonshire, United Kingdom
Royal United Hospitals Bath /ID# 251707
Bath, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 251706
Cambridge, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 251701
Liverpool, , United Kingdom
King's College Hospital NHS Foundation Trust /ID# 251705
London, , United Kingdom
Western Health and Social Care Trust /ID# 251702
Londonderry, , United Kingdom
Luton and Dunstable Hospital NHS Foundation Trust /ID# 251699
Luton, , United Kingdom
Aneurin Bevan University Health Board /ID# 251703
Newport, , United Kingdom
The Royal Wolverhampton NHS Trust /ID# 251708
Wolverhampton, , United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 244672
York, , United Kingdom
Countries
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Related Links
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Clinical Study Report Synopsis
Other Identifiers
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P20-235
Identifier Type: -
Identifier Source: org_study_id
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