Switching patients from intravenous to subcutaneous infliximab in inflammatory bowel disease

  • Gershenson, Michael (PI)
  • Abrahams, E. (CoPI)
  • Kojima, H. (CoPI)
  • Altshuler, B. L. (CoPI)
  • Maslov, D. L. (CoPI)
  • Smith, Shlon A. S.A. (PI)
  • Khaing, Myat Myat M.M. (PI)

Project Details

Description

The main study (Part 1 and Part 2) is an investigator-initiated randomised controlled trial whereby IBD patients (who are in clinical and biochemical remission) who already use intravenous infliximab will be randomised to continue intravenous or switch to subcutaneous infliximab (which has recently been TGA approved in Australia). We aim to compare outcomes after 48 weeks (including maintenance of clinical and biochemical remission, infliximab trough levels, adverse events). We will also use a knowledge and satisfaction survey for patients who are randomising to switching to subcutaneous infliximab as a secondary endpoint. For patients not involved in the randomised controlled trial but will be switching to subcutaneous infliximab regardless (based on their treating physician's decision), we will aim to recruit them in an audit (Part 3) assessing similar outcomes at 48 weeks.

StatusActive
Effective start/end date7/15/005/23/28

Funding

  • National Science Foundation: $600,000.00

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