Managing Infliximab Reinduction After Temporary Discontinuation of Drug

NCT02771457•NYU Langone Health

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects 18 years or older who are willing and able to provide informed consent
•HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
•History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
•Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
•Infliximab drug holiday for at least 12 weeks.

Exclusion Criteria

•Inability or unwillingness to provide informed consent
•Pregnant patients
•Prior history of serious infusion reaction to IFX

Key Dates

Start Date

July 1, 2016

Primary Completion Date

July 1, 2019

Completion Date

July 1, 2019

Last Updated

June 30, 2016

Conditions

Inflammatory Bowel Disease

Interventions

Infliximab at weeks 0,2, and 6

DRUG

Infliximab at weeks 0,4, and 8

DRUG

Infliximab at weeks 0 and 8

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 30, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Managing Infliximab Reinduction After Temporary Discontinuation of Drug

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Impact of Morning Light Therapy in IBD

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

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