A study to evaluate etrolizumab as a treatment for patients with moderate to severe ulcerative colitis who are naive to TNF inhibitors.
About this study
The purpose of this study is to determine whether etrolizumab is:
- A safe and effective treatment in patients with moderate to severe active ulcerative colitis that have previously had an unsuccessful response to treatment with immunosuppressants (also known as TNF inhibitors – medications that reduces the activation or efficacy of the immune system) such as azathioprine, 6-mercaptopurine, or methotrexate and/or corticosteroids
- More effective than adalimumab in treating ulcerative colitis
Adalimumab is approved by the Therapeutic Goods Administration in Australia for use in ulcerative colitis.
Anticipated enrolment close date: Ongoing
Who can take part
Inclusion criteria
- Diagnosis of moderately to severely active ulcerative colitis established at least 6 months
- Naive to treatment with any anti-TNF therapy such as adalimumab, certolizumab pegol, golimumab, and infliximab
- An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
- Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
Exclusion criteria
- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischaemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, stricture (stenosis) of the colon, toxic megacolon, or unremoved adenomatous colonic polyps, past or present ileostomy or colostomy.
What's involved
- 14 weeks of treatment, followed with a 12-week safety follow-up
- Fortnightly or monthly injections
- Vital signs (blood pressure and pulse)
- Height and weight measurements
- Blood, urine and stool samples
- Colonoscopy or sigmoidoscopy (4 times throughout the study)
- Completion of questionnaires
- Daily electronic diary
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.