This page is dedicated to the recruitment of participants for a clinical trial treatment for moderately to severely active Crohn’s Disease to be conducted by the University of the Sunshine Coast (QLD).
Full title: A Phase III, randomized, double blind, placebo-controlled, multi-centre study to evaluate the efficacy and safety of etrolizumab as an induction and maintenance treatment for patients with moderately to severely active Crohn’s Disease.
You are invited to complete a pre-assessment for this research project. This is because you have been diagnosed with Crohn’s Disease.
The research project is testing the safety and effectiveness of a potential new treatment for patients with moderately to severely active Crohn’s Disease. Please complete the following survey to express interest in participating in the above-mentioned trial.
Please be aware that completion of the survey does not guarantee entry into the trial.
Ethics approval – Bellberry Limited
If you experience difficulty completing the survey please email firstname.lastname@example.org or call 07 5456 3797.
We can only accept submissions from Australian residents. Please confirm you reside in Australia.
Are you between the ages 18 to 80 years?
Was your diagnosis of Crohn's Disease at least 3 months ago?
Do you have uncontrolled or difficult to control disease?
If female are you planning on becoming pregnant, undergo egg donation or egg harvesting in the near future?
If female, are you pregnant or lactating?
If male, are you willing to refrain from sperm donation for the duration of the trial and for approximately 6 months after?
If you are male or female, are you willing to use contraception for the duration of the clinical trial?
Do you have ulceratove colitis, indeterminate colitis, ischemic colitis, radiation colitis or a total colectomy?
Have you undergone a subtotal colectomy with ileorectal anastomosis or total colectomy?
Do you currently have any of the following complications - fixed or small bowel stenosis, short bowel syndrome, adominal or perianal abscesses?
Do you have a ileostomy or colostomy?
Do you have colonic polyps that have not been removed?
Have you had any prior treatment with etrolizumab, vedoluzimab, natalizumab or efalizumab?
Have you had any treatment with rituximab, alemtuzumab or vidilizumab in the last 12 months?
Do you have a history of active or latent tuberculosis?
Have you been on any clinical trials in the last 12 weeks?
Are you dependent on parenteral nutrition or do you expect to be in the near future?
Do you have a history of HIV, Hepatitis B or C?
Do you have congenital or acquired immune deficiency?
Do you have any uncontrolled medical conditions such as neurological, cardiac, pulmonary, renal, hepatic or endocrine?
Do you have a history of major neurological disorders including stroke, MS, brain tumour, neurodegenerative disease or poorly controlled epilepsy?
Do you have a history of cancer in the last 5 years? (except non-melanoma skin cancer)
Are you willing to visit the clinic up to 28 times over a year and a half?
Are you willing to complete a daily e-diary for the duration of the entire study?
Do you have a history of alcohol or drug abuse?
Do you have a history of organ transplant or cell transplantation?