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Randomized, double blind, prospective trial investigating the efficacy of Methotrexate in induction and maintenance of steroid free remission in ulcerative colitis (MEthotrexate Response In Treatment of UC )

Principal Investigator:   David Hudesman, MD
Time frame of study:   Ongoing
Location of Study:   Mount Sinai Beth Israel
Contact name, number and email  

Duyang Kim at 212-844-6446
DuKim@chpnet.org


Summary:
This study is funded by the National Institute of Health (NIH). The purpose of the study is to assess the effectiveness of methotrexate (MTX), a drug currently approved for use with many conditions such as Crohn’s Disease, in patients with in patients with active, moderate or severe ulcerative colitis. For the first 16 weeks participants will administrator 25mg of MTX sq, daily, by injection.  During the maintenance period (week 17-48), those who responded or are in remission (and are off steroids) will be randomized to either a 25 mg MTX once weekly or placebo once weekly. Placebo is an inactive substance that is typically referred to as “sugar pill.” In this case it is an injective without an active drug. Compensation for participation in this study is provided.


Eligibility Participants:

  • At least 18 years of age
  • Have ulcerative colitis, are steroid dependent, or have previously failed to respond to other therapies such as infliximab, azathioprine/6-MP or 5-ASA.

For additional information, or to participate, please contact Duyang Kim at 212-844-6446 or dukim@chpnet.org.