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

Study Identifier
P20-410
CT.gov Identifier
NCT04846244
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Hospital Italiano La Plata /ID# 230779
    La Plata, Buenos Aires, Argentina, 1902
    Status
    Not applicable
    Location
    CER Instituto Medico /ID# 230782
    Quilmes, Buenos Aires, Argentina, 1878
    Status
    Not applicable
    Location
    Instituto CAICI S.R.L /ID# 230781
    Rosario, Santa Fe Province, Argentina, 2000
    Status
    Not applicable
    Location
    Duplicate_CIMER /ID# 230780
    San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    Status
    Not applicable
    Location
    Clinica Regional del Sud /ID# 248866
    Río Cuarto, Argentina, 5800
    Status
    Not applicable
    Location
    Paratus Clinical Research Woden /ID# 231460
    Phillip, Australian Capital Territory, Australia, 2606
    Status
    Not applicable
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