A Clinical Study to Evaluate the Efficacy of Biologics in SpA

Spondyloarthritis (SpA) Clinical Trial

Official title:

A Clinical Study Using Damage-associated Molecular Pattern and Apparent Diffusion Coefficient to Evaluate the Efficacy of Biologics for Treating Spondyloarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399382
• Other study ID #: HKUSZH201902013
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: The University of Hong Kong-Shenzhen Hospital
• Contact: Jinxian Huang
• Phone: +86-18307555163
• Email: huangjx[@]hku-szh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis (SpA)

Intervention

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.

Locations

Country	Name	City	State
China	Jin-Xian	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong-Shenzhen Hospital

Country where clinical trial is conducted

China, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apparent Diffusion Coefficient	Apparent Diffusion Coefficient (ADC)	1 year