The Role of IGRA in Screening and Monitoring for TB During Anti TNF Therapy in Patients With IMID

The Role of Interferon Gamma Releasing Assays (IGRA) in Screening and Monitoring for Tuberculosis During Anti-TNF Therapy in Patients With Immune-mediated Inflammatory Disease (IMID)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02135289

Acronym

IGRA

Enrollment

9160

Registered

2014-05-09

Start date

2012-03-31

Completion date

2019-07-31

Last updated

2020-04-29

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

Conditions

Crohn Disease, Immune-mediated Inflammatory Disease, Inflammatory Bowel Disease, Tuberculosis, Ulcerative Colitis

Brief summary

Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID patients treated with anti-TNF can be a serious problem. This study aims to investigate the role of IGRA in screening for latent TB in IBD patients and control subjects. In part II of the study, patients of other immune-mediated inflammatory diseases (IMID) will also be included to investigate the role of serial interferon-gamma release assays (IGRA) for the diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory diseases (IMID) treated with biologics

Detailed description

The incidence of inflammatory bowel disease is rising in Hong Kong. Anti-tumor necrosis factor alpha (anti-TNF)-α is effective and increasingly being used for the treatment of patients with refractory disease and complicated disease behaviour. The reactivation of latent tuberculosis (TB) is a well-recognised complication associated with the use of anti-TNF therapy, and most cases occurred in endemic regions. Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID patients treated with anti-TNF can be a serious problem. Screening has been shown to reduce the incidence of TB, but it remains unclear whether monitoring during anti-TNF therapy is effective. Despite reported efficacy with the current screening strategy, active TB developed in up to 11.4% of patients receiving anti-TNF therapy. There is therefore an urgent need for better disease monitoring and prevention, particularly in regions where TB is endemic. Part I of this study aims to investigate the role of IGRA in screening for latent TB in IBD patients and control subjects. Part II of this study is a prospective study of serial interferon-gamma release assays (IGRA) for the diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory diseases (IMID) treated with biologics

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* patients aged 18 years or older * patients with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) for at least 3 months defined by histology or radiology

Exclusion criteria

* Patients with a previous history of TB * Patients with a positive IGRA or CXR suggesting latent tuberculosis prior to commencement of therapy

Design outcomes

Primary

Measure	Time frame	Description
IGRA positivity	2 Years	The comparison of IGRA positivity between treatment-naïve IBD patients, IBD patients on immunosuppressive drugs, and healthy controls
IGRA conversion	3 Years	The proportion and outcome of patients with IGRA conversion during anti-TNF therapy or receiving other immunosuppressive drugs

Countries

Hong Kong

Outcome results