Do you have moderate to severe ulcerative colitis and have never used TNF inhibitors?

A study to evaluate a treatement for patients with moderate to severe ulcerative colitis who are naive to TNF inhibitors

The purpose of this study is to determine whether etrolizumab is a safe and effective treatment in patients with moderate to severe active ulcerative colitis that have previously had an unsuccessful response to treatment with immunosuppressants (aka TNF inhibitors - medications that reduces the activation or efficacy of the immune system) such as azathioprine, 6-mercaptopurine, or methotrexate and/or corticosteroids and to see whether etrolizumab is more effective than adalimumab in treating ulcerative colitis. Adalimumab is approved by the Therapeutic Goods Administration in Australia for use in ulcerative colitis.

Anticipated date that enrolment will close: 31 December 2018

Who can take part

Inclusion Criteria:

  • Diagnosis of moderately to severely active Ulcerative Colitis established at least 6 months
  • Naive to treatment with any anti-TNF therapy such as adalimumab, certolizumab pegol, golimumab, and infliximab.
  • An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
  • Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, stricture (stenosis) of the colon, toxic megacolon, or unremoved adenomatous colonic polyps, past or present ileostomy or colostomy.

What is involved for you

  • 14-weeks of treatment, followed with 12-week safety follow-up
  • Fortnightly/Monthly injections
  • Vital signs (Blood Pressure and Pulse)
  • Height and Weight measurements
  • Blood, urine and stool samples
  • Colonoscopy / Sigmoidoscopy (4 times throughout the study)
  • Completion of questionnaires
  • Daily electronic diary
check
Non-Drug
Phase 1
Phase 2
Phase 3
Phase 4

For more information

Quote reference number
2014.193
Virginia Bird
+613 9342 8995
Zafirah Khan
+613 9342 7798