ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients
Trial Parameters
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Brief Summary
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
Inclusion Criteria: 1. adult of age ≥ 18 and up to 65 years; 2. diagnosis of at least one classified rheumatologic disease; and 3. being planned to receive b/tsDMARDs therapy, 4. can communicate in Chinese and/or English. Exclusion Criteria: * diagnosis of active TB diseases, * currently receiving TB or LTBI treatment; * concurrent mental illnesses; * prisoners.