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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)
Secondary ID [1] 0 0
P20-410
Universal Trial Number (UTN)
Trial acronym
UPSTAND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Axial Spondylarthritis (axSpA) 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants Receiving Upadacitinib - Participants receiving Upadacitinib for axial spondyloarthritis (axSpA).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement
Timepoint [1] 0 0
Baseline (Week 0) to Week 12
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 52

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden /ID# 231460 - Phillip
Recruitment hospital [2] 0 0
Genesis Research Services /ID# 231593 - Broadmeadow
Recruitment hospital [3] 0 0
Campbelltown Hospital /ID# 231462 - Campbelltown
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital /ID# 232417 - Camperdown
Recruitment hospital [5] 0 0
BJC Health /ID# 230066 - Paramatta
Recruitment hospital [6] 0 0
Barwon Rheumatology Services /ID# 230068 - Geelong
Recruitment hospital [7] 0 0
Peninsula Rheumatology /ID# 240172 - Langwarrin
Recruitment hospital [8] 0 0
Joint West Rheumatology /ID# 231461 - Murdoch
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
Recruitment postcode(s) [4] 0 0
2050 - Camperdown
Recruitment postcode(s) [5] 0 0
2150 - Paramatta
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3910 - Langwarrin
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Argentina
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Rio Cuarto
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Belgium
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Bruxelles-Capitale
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Belgium
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Hainaut
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Belgium
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Liege
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Belgium
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West-Vlaanderen
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Belgium
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Aalst
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Genk
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Belgium
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Oostende
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Bulgaria
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Plovdiv
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Bulgaria
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Sofiya
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Bulgaria
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Varna
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Canada
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British Columbia
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Canada
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Manitoba
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Nova Scotia
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Ontario
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Quebec
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Canada
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Saskatchewan
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France
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Doubs
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Essonne
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Ticino
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Abu Dhabi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04846244
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04846244