Last updated on July 2019

A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
  • Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
  • Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
  • Use of highly effective contraception as defined by the protocol
  • Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
  • Treatment within 5 years prior to screening with one or two induction regimines that contain TNF inhibitors (including TNF inhibitor biosimilars)

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
  • Prior or planned surgery for UC
  • Past or present ileostomy or colostomy
  • Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab) and rituximab
  • Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
  • Chronic hepatitis B or C infection, human immunodeficiency virus (HIV) or tuberculosis
  • Evidence of or treatment for Clostridium difficile clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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