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

Study Identifier
P20-235
CT.gov Identifier
NCT05170646
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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.
    Exclusion Criteria:
    * 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. * 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.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    University Hospitals of Morecambe Bay NHS Foundation Trust /ID# 242376
    Kendal, Cumbria, United Kingdom, LA9 7RG
    Status
    Not applicable
    Location
    Leicester Royal Infirmary /ID# 244674
    Leicester, England, United Kingdom, LE1 5WW
    Status
    Not applicable
    Location
    Medway NHS Foundation Trust /ID# 244673
    Gillingham, Kent, United Kingdom, ME7 5NY
    Status
    Not applicable
    Location
    Guys and St Thomas NHS Foundation Trust /ID# 251704
    London, London, City Of, United Kingdom, SE1 9RT
    Status
    Not applicable
    Location
    Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 251700
    Norwich, Norfolk, United Kingdom, NR4 7UY
    Status
    Not applicable
    Location
    Northampton General Hospital NHS Trust /ID# 251710
    Northampton, Northamptonshire, United Kingdom, NN1 5BD
    Status
    Not applicable
    Showing {first} - {last} of {total} Results