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