This trial is withdrawn!
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More info
You can access this
clinical trial
if you have
Inflammatory Bowel Disease
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.

Provided treatments

  • Drug: Infliximab at weeks 0,2, and 6
  • Drug: Infliximab at weeks 0,4, and 8
  • Drug: Infliximab at weeks 0 and 8
Tris trial is registered with FDA with number: NCT02771457. The sponsor of the trial is New York University School of Medicine and it is looking for 0 volunteers for the current phase.
Official trial title:
Managing Infliximab Reinduction After Temporary Discontinuation of Drug