A Study of the Change in Early and Sustained Pain Control in Radiographic Axial Spondylarthritis in Adult Participants Receiving Upadacitinib (UPSTAND)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    877
  • sponsor
    AbbVie
Updated on 26 May 2022

Summary

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. Despite this, there is a lack of detailed data and knowledge on pain in radiographic-axial spondyloarthritis (r-axSpA), including pain types, how it is localized, and how these different facets of pain are impacted by treatment. 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 radiographic axSpA participants.

Upadacitinib is being developed for the treatment of r-axSpA. Approximately 877 adult participants with activer-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. The overall duration of the study is approximately 30 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.

Details
Condition Radiographic Axial Spondylarthritis (r-axSpA)
Clinical Study IdentifierNCT04846244
SponsorAbbVie
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of Radiographic Axial Spondylarthritis (r-axSpA) and meeting the modified New York Criteria for r-axSpA
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at Baseline
Total back pain score ≥ 4 at Baseline
Inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to contraindication for NSAIDs as defined by the investigator
Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies

Exclusion Criteria

Prior exposure to any Janus kinase (JAK) inhibitor
Participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis
Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days
Unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires
Participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications)
Vulnerable or protected adult patients with lack of capability to give informed consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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