Managing Infliximab Reinduction After Temporary Discontinuation of Drug

June 29, 2016 updated by: NYU Langone Health
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infliximab at weeks 0,2, and 6
In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.
Drug: Infliximab at weeks 0,2, and 6
Experimental: Infliximab at weeks 0,4, and 8
In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8
Drug: Infliximab at weeks 0,4, and 8
Active Comparator: Infliximab at weeks 0, and 8
In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure Rate
Time Frame: One year
Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term clinical response
Time Frame: One year
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.
One year
Long-term clinical response
Time Frame: One year
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.
One year
Short-term changes in patient Quality of Life
Time Frame: One Year
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
One Year
Long-term changes in patient Quality of Life
Time Frame: One Year
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
One Year
Fecal calprotectin measurements
Time Frame: One year
This will be measured by ELISA kits
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Lea Chen, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-01180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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