Crohn's Disease- Gilead Study

Crohn’s disease (CD) is a relapsing and remitting form of inflammatory bowel disease (IBD) that causes gastrointestinal signs and symptoms of diarrhea, abdominal pain, weight loss, and the passage of blood or mucous per rectum. The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of clinical remission, as well as, endoscopic response in subjects with moderately to severely active Crohn's disease.

What we need:
  • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
  • Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, documented by the following:
    a) Medical record documentation of, or an ileocolonoscopy (full colonoscopy with the intubation of terminal ileum) report dated ≥ 3 months before enrollment, which shows features consistent with CD
    b) Medical record documentation of or a histopathology report showing features consistent with CD
  • No evidence of active or latent TB
  • What we cannot have:
  • Known hypersensitivity to filgotinib, its metabolites, or formulation excipients
  • Currently have any of the following complications of CD:
    a) Symptomatic strictures, OR
    b) Severe (impassable) rectal/anal stenosis, OR
    c) Fistulae other than perianal fistulae, OR
    d) Short bowel syndrome, OR
    e) Any other complications which could preclude the use of the CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with filgotinib.
  • Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to Day 1 and are not anticipated to require surgery
  • History of major surgery or trauma within 30 days prior to screening
  • Presence of UC, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
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