Humira (open label) and Methotrexate in UC

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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

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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