ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

Qualifiers

adult of age ≥ 18 and up to 65 years;

diagnosis of at least one classified rheumatologic disease; and

being planned to receive b/tsDMARDs therapy,

can communicate in Chinese and/or English.

Disqualifiers

diagnosis of active TB diseases,

currently receiving TB or LTBI treatment;

concurrent mental illnesses;

prisoners.

Trial design

Treatments tested in this trial

  • ESAT6/CFP10 skin test

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

2
China
S.H. Ho Research Centre for Infectious Diseases0000, Hong KongHong Kong, China
Hong Kong
S.H. Ho Research Centre for Infectious Diseases0000, ShatinHong Kong, Hong Kong

Sponsors and collaborators

Chinese University of Hong Kong

Lead sponsor