Familial GI Cancers Unit

Crohn’s Disease Study involving an investigational subcutaneous medication (PF-04236921)). Double-blind, placebo-controlled study.

Details of Research

Contact: Shelley Mikolainis, Study Coordinator
E-mail: smikolainis@mtsinai.on.ca

Etrolizumab in UC: Etrolizumab/placebo for anti-TNF naive patients

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: Open label for 10 weeks then responders will go into a blinded Maintenance phase, open label extension study possible at week 62 or after week 10 for nonresponders

Eligibility

  • Mayo score 6 -12 (bleeding subscore >1)
  • Naive to anti-TNF therapy
  • Inadequate response, loss of response to or intolerance to immunomodulators/steroids within past 5 years
  • Subcutaneous injection


Exclusions
: strictures, prior tx with anti-integrin agents (vedolizumab)

APD334-003 (S1P1 receptor antagonist) in UC

Details of Research

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

Primary Investigator: Dr. Hillary Steinhart

Enrolment: Ongoing

Expectations: oral once daily, (1 mg, 2 mg or placebo), may be eligible open label study

Eligibility

  • Mayo score (3 component) 4-9 (bleeding subscore >1)
  • inadequate response, loss of response to or intolerance to 5-ASA,  immunomodulators/steroids, TNF?, or integrin antagonists within past 5 years
  • TNF?, or integrin antagonists washout is 60 days prior to Day 1
  • immunosuppresants are discontinued at Day 1


Exclusions
: previous treatment with more than 2 biologic agents, history of retinal macular edema

Etrolizumab in UC: Etrolizumab/placebo for patients who are refractory/intolerant to TNF inhibitors

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: completed, Cohort 2: drug/placebo 4:1 ratio for 14 weeks, following week 14 is the Maintenance phase for those who are responders, they will receive either drug/placebo, open label extension possible for non-responders

Eligibility

  • Mayo score 6-12 (bleeding subscore >1)
  • Anti-TNF washout – 8weeks prior to Day 1
  • Intolerant or refractory to either: Infliximab, Adalimumab or Golimumab within past 5 years or recurrence or symptoms or intolerance
  • Subcutaneous injection


Exclusions: strictures, prior tx with anti-integrin agents (vedolizumab)

Humira (open label) and Methotrexate in UC

Details of Research

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

Primary Investigator: Dr. Hillary Steinhart

Enrolment: Ongoing

Eligibility

  • anti-TNF naive
  • Mtx naive
  • open label Humira with or without Mtx (2 dose  levels of Mtx or placebo)
  • PK study (21 blood draws), must be available to return to clinic
  • flex sig (Shelley must record it) during screening and at week 18 (study end) or EW
  • mod to severe UC with Mayo > 6 (endo subscore must be > 2 by central reader)
  • meds allowed: prednisone (max 40 mg/d)

Exclusions: disease limited to rectum, prior ant-TNF, prior Methotrexate, Imuran washout is 30 days

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