Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Status:
Withdrawn
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health