A Clinical Study to Evaluate the Efficacy of Biologics in SpA
NCT ID: NCT04399382
Last Updated: 2022-06-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
40 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-01-12
Study Completion Date
2022-12-31
Brief Summary
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Spondyloarthritis (SpA) is one of the potentially debilitating inflammatory diseases that affect the whole body, primarily burdening the sacroiliac joints and the spine. It mostly affects young and middle aged adults. SpA can be classified to non-radiographic axial SpA (nr-axSpA) and radiographic axSpA (r-axSpA). The latter is ankylosing spondylitis (AS). The key to its early treatment is the radiological detection and management of sacroiliitis. To date, biologics is the most powerful anti-inflammatory drug. Recent research has shown that diffusion-weighted imaging (DWI) outperforms the sequence recommended by the Guidelines in diagnosing inflammation and assessing disease activity. Preliminary research conducted by our team has also demonstrated that apparent diffusion coefficient (ADC) is a valuable imaging biomarker. However, to date, no serum maker of comparable effectiveness has been identified. Damage-Associated Molecular Pattern (DAMP), including S100A8 and S100A9, high mobility group protein B1 (HMGB1) and Tenascin-C (TNC), may play a role in inflammation by regulating the TLR4/MyD88/NF-κB signaling pathways. The present study will enroll 20 patients with nr-axSpA and 20 patients with AS. It will utilize serum DAMP and ADC to assess disease activity before and after treatment as well as the change in and correlations of treatment outcomes, in order to identify objective and quantifiable serum and imaging markers that are beneficial in clinical applications. ADC is the primary outcome. The main hypothesis is that disease activity as measured by ADC will be reduced after 1 year of treatment from baseline as compared to before treatment at baseline. Study findings will indicate the utility of ADC as an objective indicator of disease activity for guiding therapeutic approaches and improving dosage adjustment in clinical applications.
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Detailed Description
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Conditions
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Spondyloarthritis (SpA)
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Non-radiographic group
Participants with non-radiographic axial SpA
Biologics
Intervention Type
DRUG
The exposure of interest in this observational study is the biological therapy of Tumor Necrosis Factor (TNF) inhibitor, specifically etanercept biosmilar/ infliximab/ adalimumab/ golimumab.
Radiographic group
Participants with radiographic axial SpA (a.k.a. ankylosing spondylitis)
Biologics
Intervention Type
DRUG
The exposure of interest in this observational study is the biological therapy of Tumor Necrosis Factor (TNF) inhibitor, specifically etanercept biosmilar/ infliximab/ adalimumab/ golimumab.
Interventions
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Biologics
The exposure of interest in this observational study is the biological therapy of Tumor Necrosis Factor (TNF) inhibitor, specifically etanercept biosmilar/ infliximab/ adalimumab/ golimumab.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
\- Diagnosed with non-radiographic or radiographic axial SpA
Exclusion Criteria
* Unable to provide written consent
* Unable to undergo MRI examination
* Pregnancy
* Unable to read and/or write Chinese
* Unable to undergo MRI examination
* Pregnancy
* Unable to read and/or write Chinese
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The University of Hong Kong-Shenzhen Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Jin-Xian
Shenzhen, Guangdong / 广东, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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HKUSZH201902013
Identifier Type: -
Identifier Source: org_study_id
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