Inflammatory Bowel DiseaseIGRANCT02135289
The Role of IGRA in Screening and Monitoring for TB During Anti TNF Therapy in Patients With IMID
An observational study of Inflammatory Bowel Disease and Crohn Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis
- How many people
- 9,160 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2012to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending Prince of Wales Hospital
Who may be able to join
- 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
Who cannot join
- Patients with a previous history of TB
- Patients with a positive IGRA or CXR suggesting latent tuberculosis prior to commencement of therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
Read the 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
- Conditions
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Tuberculosis, Immune-mediated Inflammatory Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IMID patients | Patients with IMID | |
| Control - subjects without IBD | Patients without IBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGRA positivity
The comparison of IGRA positivity between treatment-naïve IBD patients, IBD patients on immunosuppressive drugs, and healthy controls
Measured: 2 Years
IGRA conversion
The proportion and outcome of patients with IGRA conversion during anti-TNF therapy or receiving other immunosuppressive drugs
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMar 2012
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
- Investigators
- Siew Chien Ng, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135289
- Sponsor's protocol ID
- IGRA
- Acronym
- IGRA
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2014
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02135289
- Acronym / sponsor ID
- IGRA / IGRA
- Conditions
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Tuberculosis, Immune-mediated Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,160 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMID patients | – | –Patients with IMID |
| Control - subjects without IBD | – | –Patients without IBD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending Prince of Wales Hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with a previous history of TB
- Patients with a positive IGRA or CXR suggesting latent tuberculosis prior to commencement of therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IGRA positivity
Time frame: 2 Years
The comparison of IGRA positivity between treatment-naïve IBD patients, IBD patients on immunosuppressive drugs, and healthy controls
IGRA conversion
Time frame: 3 Years
The proportion and outcome of patients with IGRA conversion during anti-TNF therapy or receiving other immunosuppressive drugs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siew Chien Ng principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Crohn Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGRA positivity (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.