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 Crohn’s Disease, to be conducted by the University of the Sunshine Coast (QLD) in partnership with Coastal Digestive Health.
Full title: Combined Phase 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 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 an investigational medication 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
Are you between the ages 18 to 75 years?
Was your diagnosis at least 6 months ago?
Is your condition uncontrolled or difficult to control?
Do you have more than 6 bloody stools per day?
If female, are you pregnant or lactating?
If female, are you planning on becoming pregnant, undergoing egg donation or egg harvesting in the near future?
Are you willing to use contraception for the duration of the clinical trial?
If male, are you willing to refrain from sperm donation for the duration of the trial and at least 90 days after?
Do you have a known sensitivity to filgotinib? If you do not know what filgotinib is, please select 'No'
Have you had any prior surgical intervention for your disease, or are you likely to require this in the near future?
Are you dependent on parenteral nutrition?
Do you have a history of HIV, Hepatitis B or C?
Do you have a history of cancer in the last 5 years?
Do you have a history of lymphoma, leukaemia, myeloproliferative or lymphoproliferative disorder?
Are you willing to visit the clinic about 13 times over 58 weeks?
Are you willing to complete a daily e-diary for the duration of the study?