Prospective Study of Mycobacterium Tuberculosis Specific Cellular immune Responses in Iatrogenically Immunosuppressed Patients: those undergoing TNF-alpha blockade or Awaiting Renal Trasnplants: A Potential New Method For Accurate Diagnosis of Latent Tuberculosis Infection in Clinical Practice - Diagnosis of Latent TB Infection in Anti-TNF alpha or Dialysis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005664-88-GB

Enrollment

520

Registered

2005-12-15

Start date

2006-12-08

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal failure and iatrogenic immunosuppression associated with solid organ transplantation or TNF alpha blockade in rheumatoid arthritis ICD 10 codes included: N18 Z94.0 M05 M06 M07 M45

Interventions

Trade Name: Tuberculin PPD RT 23 SSI for mantoux testing Product Name: Tuberculin PPD RT 23 SSI for mantoux testing Product Code: 1 Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients in chronic renal failure who are potential transplant recipients OR Patients with a rheumatological condition who are potential recipients of Tumour Necrosis Factor alpha blockade AND adult (over 18) AND able to give written informed consent AND with risk factors for tuberculosis: -[renal arm] from collaborating units in high prevalence areas of the UK -[anti TNF alpha arm] patients who would be considered for tuberculin skin testing under current anti-TNFalpha treatment guidelines, including past history of exposure or disease, immigrant from high prevalence area, CXR changes suggestive of prior TB, grade 2 heaf test or above Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Children Current active tuberculosis Unable to give written informed consent Hypersensitivity to tuberculin

Design outcomes

Primary

Measure	Time frame
Main Objective: To validate the use of the RD1 based Exvivo IFNy ELISpot in the immunodiagnosis of tuberculosis in iatrogenically immunosuppressed populations by calculation of positive and negative predictive values for the assay and for a comparator: the tuberculin based mantoux test;Secondary Objective: To investigate potential immune correlates of latency and active disease in tuberculosis and identify potential markers of prognosis and disease progression in tuberculosis.;Primary end point(s): Development of active tuberculosis	—

Measure

Time frame

Main Objective: To validate the use of the RD1 based Exvivo IFNy ELISpot in the immunodiagnosis of tuberculosis in iatrogenically immunosuppressed populations by calculation of positive and negative predictive values for the assay and for a comparator: the tuberculin based mantoux test;Secondary Objective: To investigate potential immune correlates of latency and active disease in tuberculosis and identify potential markers of prognosis and disease progression in tuberculosis.;Primary end point(s): Development of active tuberculosis

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026