Managing Infliximab Reinduction After Temporary Discontinuation of Drug

NYU Langone Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Inflammatory Bowel Disease

Interventions

Infliximab at weeks 0,2, and 6DRUG

Infliximab at weeks 0,4, and 8DRUG

Infliximab at weeks 0 and 8DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Failure Rate

Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.

Time frame: One year

Secondary Outcomes

Short-term clinical response

The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.

Time frame: One year

Long-term clinical response

The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.

Time frame: One year

Short-term changes in patient Quality of Life

This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

Time frame: One Year

Long-term changes in patient Quality of Life

This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

Time frame: One Year

Fecal calprotectin measurements

This will be measured by ELISA kits

Time frame: One year

Data from ClinicalTrials.gov

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