Etrolizumab in CD

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Details of Research

Contact: Shelley Mikolainis, Research Coordinator
416-586-4800 ext 4989
smikolainis@mtsinai.on.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

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