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Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants. Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Italiano La Plata /ID# 230779
La Plata, Buenos Aires, Argentina
CER Instituto Medico /ID# 230782
Quilmes, Buenos Aires, Argentina
Instituto CAICI S.R.L /ID# 230781
Rosario, Santa Fe Province, Argentina
Duplicate_CIMER /ID# 230780
San Miguel de Tucumán, Tucumán Province, Argentina
Clinica Regional del Sud /ID# 248866
Río Cuarto, Argentina
Paratus Clinical Research Woden /ID# 231460
Phillip, Australian Capital Territory, Australia
Genesis Research Services /ID# 231593
Broadmeadow, New South Wales, Australia
Campbelltown Hospital /ID# 231462
Campbelltown, New South Wales, Australia
Royal Prince Alfred Hospital /ID# 232417
Camperdown, New South Wales, Australia
BJC Health /ID# 230066
Paramatta, New South Wales, Australia
Start Date
April 30, 2021
Primary Completion Date
March 24, 2025
Completion Date
March 24, 2025
Last Updated
April 3, 2025
708
ACTUAL participants
Lead Sponsor
AbbVie
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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