New Skin Test for Hidden Tuberculosis Before Rheumatology Treatment
Tests a new skin test for latent tuberculosis in adults with rheumatic diseases.
Key facts
- Who runs it
- Chinese University of Hong Kong
- Where
- Shatin, Hong KongSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 19 Mar 2025
- Expected to end
- Aug 2028
- Type of study
- Observational
- Treatments tested
- ESAT6/CFP10 skin test
- Record updated
- 10 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a rheumatologic disease who are about to start a biologic or targeted synthetic DMARD. It tests a new skin test for TB infection.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- At least one diagnosed rheumatologic disease. Active TB disease is not allowed.
- Earlier treatment
- Planned to start b/tsDMARD therapy. Must not be on TB or latent TB infection treatment now.
Main reasons for not taking part
- Active TB disease
- Currently receiving TB or latent TB infection treatment
- Concurrent mental illness
- Prisoners
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- currently receiving TB or LTBI treatment
- concurrent mental illnesses
- diagnosis of active TB diseases,
- prisoners
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Hong Kong
Also in 1 other country, 1 site
- S.H. Ho Research Centre for Infectious DiseasesShatin, Hong KongContact: Shui Shan Lee, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- study group
Adult patients with diagnosed rheumatologic diseases scheduled to receive b/tsDMARDs therapy
Treatment: ESAT6/CFP10 skin test
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Use of a Novel ESAT6/CFP10 Skin Test in Diagnosis of Latent Tuberculosis Infection Among Rheumatologic Patients
- Plain-language title
- New Skin Test for Hidden Tuberculosis Before Rheumatology TreatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06796647, who can take part
- Record updated
- 10 September 2025