UPSTAND

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

Brief 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.

Observational study

Status:
Recruiting
Conditions:
Radiographic Axial Spondylarthritis (r-axSpA)
Enrollment:
877 patients
Protocol ID:
P20-410
Observational model:
Cohort
Time perspective:
Prospective

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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.

All the cities where the clinical studies are located

Vancouver - V5Z 1J9
Sydney - B1S 3N1
Dundas - L9H 1B7
Hamilton - L8N 1Y2
Mississauga - L5M 2V8
Windsor - N8X 1T3
Montréal - H4A 3T2
Sainte-foy - G1V 3M7
Sherbrooke - J1G 2E8
Saskatoon - S7K 3H3
Winnipeg - R3A 1M3
Winnipeg - R3N 0K6