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:
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
What we cannot have:
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.