Status:
COMPLETED
A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib
Lead Sponsor:
AbbVie
Conditions:
Axial Spondylarthritis (axSpA)
Eligibility:
All Genders
18+ years
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 24 2025
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT04846244
Start Date
April 30 2021
End Date
March 24 2025
Last Update
April 3 2025
Active Locations (160)
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1
Hospital Italiano La Plata /ID# 230779
La Plata, Buenos Aires, Argentina, 1902
2
CER Instituto Medico /ID# 230782
Quilmes, Buenos Aires, Argentina, 1878
3
Instituto CAICI S.R.L /ID# 230781
Rosario, Santa Fe Province, Argentina, 2000
4
Duplicate_CIMER /ID# 230780
San Miguel de Tucumán, Tucumán Province, Argentina, 4000