A Study to Assess Disease Activity in Adult Participants With Ankylosing Spondylitis Who Receive Upadacitinib in a Real-world Setting (UpSPINE)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    352
  • sponsor
    AbbVie
Updated on 30 April 2022

Summary

Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis [AS]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain that might be difficult to distinguish from other causes of chronic back pain. 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 352 adult participants with active r-axSpA will be enrolled in Germany.

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 52 weeks.

There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. 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)
Treatment Upadacitinib
Clinical Study IdentifierNCT05094128
SponsorAbbVie
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of r-axSpA upon physician's judgement
Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study
Upadacitinib prescribed in accordance with the local label

Exclusion Criteria

Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib)
Participants with primary fibromyalgia (upon physician´s judgement)
Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study
Participants who cannot be treated with upadacitinib according to the applicable local label
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