NCT06796647|Recruiting
ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients
The Use of a Novel ESAT6/CFP10 Skin Test in Diagnosis of Latent Tuberculosis Infection Among Rheumatologic Patients
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The Use of a Novel ESAT6/CFP10 Skin Test in Diagnosis of Latent Tuberculosis Infection Among Rheumatologic Patients
Sponsor study identifier
observational
100
2 countries
2
Study Start
March 19, 2025
Actual (reported)Primary Completion
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2025
Actual (reported)January 28, 2025
Actual (reported)March 19, 2025
Actual (reported)February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
C-TST reading
Concordance between C-TST and standard TST
from enrolment to reading test result at 48-72 hours
C-TST reading
Concordance between C-TST and IGRA test result
from enrolment to reading test result at 2 weeks
Proportion with TB disease
from enrolment to last followup at 2 years
Adult patients with diagnosed rheumatologic diseases scheduled to receive b/tsDMARDs therapy
Each recruited participant would be offered standard tuberculin skin test (TST) and ESAT6/CFP10 (C-TST) skin test on the same day or setting of clinical visit. TST and C-TST would be performed by the Mantoux technique with intradermal injection of 2U purified protein derivative-RT23 on one forearm and 5U (1.0µg/0.1 ml) of recombinant fusion protein ESAT6-CFP10 on the other forearm respectively.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rheumatology patients followed up at the Specialist Services of regional hospitals in New Territories East Cluster in Hong Kong (Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital)
S.H. Ho Research Centre for Infectious Diseases
Hong Kong, Hong Kong, 0000, China
S.H. Ho Research Centre for Infectious Diseases
Shatin, Hong Kong, 0000, Hong Kong
David SC Hui, MD
Chinese University of Hong Kong
First Submitted
January 22, 2025
First Posted
January 28, 2025
Study Start
March 19, 2025
Actual (reported)Primary Completion
February 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 10, 2025
Record last verified: 2025-09
Access of individual level data at individual level is restricted for protection of privacy, as stipulated in the institutional approval
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Source: ClinicalTrials.gov.
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