Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT06796647

ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

Led by Chinese University of Hong Kong · Updated on 2025-09-10

100

Participants Needed

2

Research Sites

175 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD). This is a prospective observational study involving the recruitment of patients with rheumatologic diseases who are planned for initiation of b/tsDMARD. Eligible patients would undergo skin testing by the Mantoux technique with purified protein derivative (PPD) RT23 on one forearm and C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay. The skin test results would be read within 48-72 hours afterwards. Treatment of TB infection would be provided in accordance with current clinical guidelines, followed by regular clinical monitoring for 2 years. Analyses involve performance evaluation of C-TST, and decision-analytical modelling incorporating multiple Markov process to evaluate the impact of management by LTBI testing methods on clinical outcomes and health care costs.

CONDITIONS

Official Title

ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosed with at least one classified rheumatologic disease
  • Planned to receive biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) therapy
  • Able to communicate in Chinese and/or English
Not Eligible

You will not qualify if you...

  • Diagnosis of active tuberculosis disease
  • Currently receiving treatment for tuberculosis or latent tuberculosis infection
  • Presence of concurrent mental illnesses
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

S.H. Ho Research Centre for Infectious Diseases

Hong Kong, Hong Kong, China, 0000

Actively Recruiting

2

S.H. Ho Research Centre for Infectious Diseases

Shatin, Hong Kong, Hong Kong, 0000

Not Yet Recruiting

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Research Team

S

Shui Shan Lee, MD

CONTACT

H

Ho So, FRCP

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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