NCT02771457

Managing Infliximab Reinduction After Temporary Discontinuation of Drug

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Infliximab at weeks 0,2, and 6
DRUG	Infliximab at weeks 0,4, and 8
DRUG	Infliximab at weeks 0 and 8	For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks.

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2016-05-13
• Last updated: 2016-06-30