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NCT Number: NCT02135289

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. IGRA positivity

    Time frame: 2 Years

    The comparison of IGRA positivity between treatment-naïve IBD patients, IBD patients on immunosuppressive drugs, and healthy controls

  2. IGRA conversion

    Time frame: 3 Years

    The proportion and outcome of patients with IGRA conversion during anti-TNF therapy or receiving other immunosuppressive drugs

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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)

Acronym: IGRA

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
May 9, 2014
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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