Etrolizumab in CD

Details of Research

Contact: Shelley Mikolainis, Research Coordinator
416-586-4800 ext 4989
Shelley.Mikolainis@SinaiHealth.ca

Primary Investigator: Dr. Hillary Steinhart

Enrolment: Ongoing

Expectation: Cohort 1 will receive placebo, etrolizumab 105 mg SC Q4W (low dose), or etrolizumab 210 mg SC (high dose) 1:2:2 x 14-weeks, Cohort 2 will receive low-dose or high-dose regimens of etrolizumab. Cohort 3  will be randomized in a 2:3:3 ratio to receive placebo or etrolizumab low-dose or high-dose. Patients may be eligible for open-label treatment at week 14 of for entry into the Maintenance phase

Eligibility

• intolerance, refractory disease or no response to at least one of: Corticosteroids, immunomodulators or anti-TNF therapy within past 5 years
• Anti-TNF washout is 8 weeks prior to baseline
• infection treated with IV or oral antibiotics within last 4 weeks

Exclusion: draining fistula