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NCT05170646Completed

An Observational Study to Assess the Real-World Effectiveness of Upadacitinib in Adult Participants With Rheumatoid Arthritis

Real World Clinical and Patient-Reported Outcomes of Patients With Moderate-to-Severe Rheumatoid Arthritis Initiating Upadacitinib in the United Kingdom: A Prospective, Observational Cohort Study

Source: ClinicalTrials.gov · Last updated 29 Apr 2025

Brief summary (registry, in English)

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study will assess the clinical and patient-reported outcomes with upadacitinib in adult participants with moderate-to-severe RA in a real-world setting. 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.

Status (registry)
Completed
Study type
Observational
Enrollment
97 (actual)
First submitted
16 Nov 2021
Start date
Mar 2022
Primary completion date
Jan 2024
Lead sponsor
AbbVie
NCT number
NCT05170646

What you commit to

  • Study type: Observational
  • Participants enrolled: 97
  • From Mar 2022 to the primary completion date, Jan 2024
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • First dose of upadacitinib received prior to enrollment in the study (same day permitted) or more than 28 days after enrolment into the study.
  • 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.
  • Participation in any interventional clinical trial within the 3 months prior to initiation or at any point during the study observation period.

Other illness

  • In the opinion of the treating clinician, participant symptoms are predominately being driven by fibromyalgia or unrelated pain component instead of underlying inflammatory disease.

Who the study is looking for

  • American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) confirmed diagnosis of rheumatoid arthritis (RA).
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal United Hospitals Bath /ID# 251707
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BathUnited KingdomUnknown status
Cambridge University Hospitals NHS Foundation Trust /ID# 251706
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CambridgeUnited KingdomUnknown status
Medway NHS Foundation Trust /ID# 244673
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GillinghamUnited KingdomUnknown status
University Hospitals of Morecambe Bay NHS Foundation Trust /ID# 242376
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KendalUnited KingdomUnknown status
Leicester Royal Infirmary /ID# 244674
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LeicesterUnited KingdomUnknown status
Liverpool University Hospitals NHS Foundation Trust /ID# 251701
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LiverpoolUnited KingdomUnknown status
Guys and St Thomas NHS Foundation Trust /ID# 251704
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LondonUnited KingdomUnknown status
King's College Hospital NHS Foundation Trust /ID# 251705
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LondonUnited KingdomUnknown status
Western Health and Social Care Trust /ID# 251702
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LondonderryUnited KingdomUnknown status
Luton and Dunstable Hospital NHS Foundation Trust /ID# 251699
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LutonUnited KingdomUnknown status
Aneurin Bevan University Health Board /ID# 251703
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NewportUnited KingdomUnknown status
Northampton General Hospital NHS Trust /ID# 251710
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NorthamptonUnited KingdomUnknown status
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 251700
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NorwichUnited KingdomUnknown status
The Royal Wolverhampton NHS Trust /ID# 251708
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WolverhamptonUnited KingdomUnknown status
York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 244672
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YorkUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.