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A Clinical Study to Evaluate the Efficacy of Biologics in SpA

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ClinicalTrials.gov Identifier: NCT04399382
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong-Shenzhen Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Spondyloarthritis (SpA) Drug: Biologics

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Study Using Damage-associated Molecular Pattern and Apparent Diffusion Coefficient to Evaluate the Efficacy of Biologics for Treating Spondyloarthritis
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Group/Cohort Intervention/treatment
Non-radiographic group
Participants with non-radiographic axial SpA
Drug: 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.

Radiographic group
Participants with radiographic axial SpA (a.k.a. ankylosing spondylitis)
Drug: 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.




Primary Outcome Measures :
  1. Apparent Diffusion Coefficient [ Time Frame: 1 year ]
    Apparent Diffusion Coefficient (ADC)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with axial SpA who attend the rheumatology clinic of The University of Hong Kong-Shenzhen Hospital will be screened consecutively by the PI, her trained nurses, and/or research assistants for eligibility. Eligible patients will be recruited to participate in the study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399382


Contacts
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Contact: Jinxian Huang +86-18307555163 huangjx@hku-szh.org

Sponsors and Collaborators
The University of Hong Kong-Shenzhen Hospital
Publications:

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Responsible Party: The University of Hong Kong-Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT04399382    
Other Study ID Numbers: HKUSZH201902013
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong-Shenzhen Hospital:
MRI
Apparent Diffusion Coefficient
Biomarker
Damage-Associated Molecular Pattern
Chinese
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases