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

NCT02135289 | Completed DMC

• 1 other identifier: IGRA
• Study Type: observational
• Target: 9,160
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• IGRA positivity

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

  2 Years

• IGRA conversion

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

  3 Years

Study Arms (2)

IMID patients

Patients with IMID

Control - subjects without IBD

Patients without IBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending Prince of Wales Hospital

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Tuberculosis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Siew Chien Ng

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 9, 2014
• Study Start: March 1, 2012
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)