Ulcerative Colitis

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Ulcerative Colitis


Have you been diagnosed with Ulcerative Colitis?

This page is dedicated to the recruitment of participants for a clinical trial of an investigational product for induction and maintenance of remission of moderately to severely active Ulcerative Colitis to be conducted by the University of the Sunshine Coast (QLD).

Full title: Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

You are invited to complete a pre-assessment for this research project. This is because you have been diagnosed with Ulcerative Colitis.

The research project is testing the safety and effectiveness of an investigational medication for patients with moderately to severely active Ulcerative Colitis. 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 trials@usc.edu.au

Start Questionnaire?
We can only accept submissions from Australian residents. Please confirm you reside in Australia.
1. Are you between 18 and 75 years of age?
2. Was your diagnosis of Ulcerative Colitis at least 6 months ago?
3. Do you have uncontrolled or difficult to control disease?
4. Do you have more than 6 bloody stools per day and one or more of the following:Fever greater than or equal to 38 °C or high pulse greater than or equal to 90 beats per minute?
5. If female, are you pregnant or lactating?
6. If female, are you planning on becoming pregnant, undergo egg donation or egg harvesting in the near future?
7. Are you willing to use contraception for the duration of the clinical trial?
8. If male, are you willing to refrain from sperm donation for the duration of the trial and for at least 90 days after?
9. Do you have a known sensitivity to filgotinib? If you do not know what filgotinib is, please select ‘No’.
10. Do you have Crohn’s Disease, indeterminate colitis, ischemic colitis, fulminant colitis or toxic mega-colon?
11. Have you had any prior surgical intervention for Ulcerative Colitis (e.g. colectomy, partial colectomy, ileostomy, or colostomy) or likely to require in the near future?
12. Are you dependent on parenteral nutrition?
13. Do you have a history of HIV, Hepatitis B or C?
14. Do you have a history of cancer in the last 5 years (except non-melanoma skin cancer or cervical cancer?
15. Do you have any history of lymphoma, leukaemia, myeloproliferative or lymphoproliferative disorder?
16. Are you willing to visit the clinic about 13 times over 58 weeks?
17. Are you willing to complete a daily e-diary for the duration of the study?
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