Crohn’s Disease Study 2

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Crohn’s Disease Study 2

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Have you been diagnosed with Crohns Disease?

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 Crohns Disease to be conducted by the University of the Sunshine Coast (QLD).

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 take part in this research project. This is because you have been diagnosed with Crohns Disease.

The research project is testing the safety and effectiveness of an investigational medication for patients with moderately to severely active Crohns Disease. Please complete the following survery 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

Are you between the ages of 18 to 75 years?
Was your diagnosis of Crohn's Disease at least 6 months ago?
Do you have uncontrolled or difficult to control disease?
Do you have more than 6 bloody stools per day and a fever greater than or equal to 38 ˚C or a high pulse greater than or equal to 90 beats per minute?
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?
If male, are you willing to refrain from sperm donation for the duration of the trial and for at least 90 days after
Are you willing to use contraception for the duration of the clinical trial
Do you have a known sensitivity to filgotinib? If you do not know what filgotinib is, please select ‘No’.
Do you currently have any of the following Crohn’s Disease complications – symptomatic stricture, rectal or anal stenosis, fistulae, or short bowel syndrome?
Do you have ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis or toxic mega-colon?
Have you had any prior surgical intervention for Crohn’s Disease (e.g. colectomy, partial colectomy, ileostomy, or colostomy) or likely to require in the near future?
Are you dependent on parenteral nutrition?
Do you have a history of HIV, Hepatitis B or Hepatitis C
Do you have a history of cancer in the last 5 years (except non-melanoma skin cancer or cervical cancer)?
Do you have any history of lymphoma, leukemia, 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?
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