Inflammatory Bowel Disease Chart Review
Research type
Research Study
Full title
Retrospective Observational Study to Describe Treatment Patterns and Health Care Resource Utilisation Associated with Anti-Tumor Necrosis Factor (TNF) Therapy in Patients Diagnosed with Crohn’s Disease (CD) or Ulcerative Colitis (UC)
IRAS ID
151503
Contact name
James Oliver Lindsay
Contact email
Sponsor organisation
Takeda Pharmaceuticals International, Inc.
Research summary
Anti TNF medicines are highly effective in moderate to severe Chrohn’s Disease (CD) and Ulcerative Colitis (UC), but a considerable portion of patients will not respond (primary nonresponders) or will lose response to anti-TNF agents (secondary loss of response) over time. Of the patients who initially respond and then lose response over time, many experience symptoms and require dose escalation, switching to another anti-TNF, surgery, or adding other medications.
Data on treatment patterns of anti-TNFs, which are biologic drugs, may be used to classify patients as primary non-responders and secondary loss of response to therapy, however, available data on treatment patterns of anti-TNF use among patients with CD and UC in clinical practice is limited.
This study is undertaken to describe the treatment patterns of anti-TNF use among patients diagnosed with UC and CD in clinical practice. The treatment patterns will be used to categorise patients into primary responders/non-responders and secondary loss of response to anti-TNF therapy in normal clinical care.
The aim of this study is to provide real-world evidence of treatment patterns, health care resource utilisation (HCRU), and associated health care costs in adult patients who have initiated anti-TNF therapy for the treatment of CD or UC.
The study will be carried out in the gastroenterology departments of NHS general hospitals. Patients with CD who received their first dose of anti-TNF between 01 June 2009 - 01 Jun 2011 and patients with UC who received their first dose of anti-TNF between 01 June 2009 - 01 June 2013 (the Eligibility Period), will be considered for study participation. Data will be collected retrospectively from the patient notes for all enrolled patients and therefore no additional visits or laboratory tests will be required. Data abstraction is expected to be completed by October 2014.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1047
Date of REC Opinion
17 Jun 2014
REC opinion
Favourable Opinion