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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04846244
Registration number
NCT04846244
Ethics application status
Date submitted
13/04/2021
Date registered
15/04/2021
Date last updated
22/03/2024
Titles & IDs
Public title
A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib
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Scientific title
Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)
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Secondary ID [1]
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P20-410
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Universal Trial Number (UTN)
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Trial acronym
UPSTAND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Axial Spondylarthritis (axSpA)
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0
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Condition category
Condition code
Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
0
0
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants Receiving Upadacitinib - Participants receiving Upadacitinib for axial spondyloarthritis (axSpA).
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement
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Assessment method [1]
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Total spinal pain consists of the mean of two 0-10 numerical rating scale (NRS) questions: total back pain during the previous week and nocturnal back pain during the previous week.
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Timepoint [1]
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Baseline (Week 0) to Week 12
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Primary outcome [2]
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Percentage of Participants Maintaining Total Spinal Pain < 4 Among Participants Who Achieved Total Spinal Pain < 4 and >= 2 unit (0 - 10) Improvement from Baseline at Week 12
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Assessment method [2]
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Total spinal pain score consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.
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Timepoint [2]
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Week 52
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Eligibility
Key inclusion criteria
- Clinical diagnosis of Axial Spondylarthritis (axSpA) according to the ASAS criteria.
- 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2025
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Actual
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Sample size
Target
650
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
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Recruitment hospital [1]
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Paratus Clinical Research Woden /ID# 231460 - Phillip
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Recruitment hospital [2]
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Genesis Research Services /ID# 231593 - Broadmeadow
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Campbelltown Hospital /ID# 231462 - Campbelltown
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Royal Prince Alfred Hospital /ID# 232417 - Camperdown
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BJC Health /ID# 230066 - Paramatta
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Barwon Rheumatology Services /ID# 230068 - Geelong
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Peninsula Rheumatology /ID# 240172 - Langwarrin
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Joint West Rheumatology /ID# 231461 - Murdoch
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2606 - Phillip
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2292 - Broadmeadow
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2560 - Campbelltown
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2050 - Camperdown
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2150 - Paramatta
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3220 - Geelong
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3910 - Langwarrin
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
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Name
AbbVie
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Summary
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. 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04846244
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04846244
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