Back to resultsManaging Infliximab Reinduction After Temporary Discontinuation of Drug
Primary Purpose
Inflammatory Bowel Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Infliximab at weeks 0,2, and 6
Infliximab at weeks 0,4, and 8
Infliximab at weeks 0 and 8
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Influximab, IFX, Remicade
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Infliximab at weeks 0,2, and 6
Infliximab at weeks 0,4, and 8
Infliximab at weeks 0, and 8
Arm Description
In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.
In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8
In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8.
Outcomes
Primary Outcome Measures
Failure Rate
Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.
Secondary Outcome Measures
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.
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.
Short-term changes in patient Quality of Life
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Long-term changes in patient Quality of Life
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Fecal calprotectin measurements
This will be measured by ELISA kits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02771457
Brief Title
Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Official Title
Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Influximab, IFX, Remicade
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infliximab at weeks 0,2, and 6
Arm Type
Experimental
Arm Description
In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.
Arm Title
Infliximab at weeks 0,4, and 8
Arm Type
Experimental
Arm Description
In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8
Arm Title
Infliximab at weeks 0, and 8
Arm Type
Active Comparator
Arm Description
In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8.
Intervention Type
Drug
Intervention Name(s)
Infliximab at weeks 0,2, and 6
Intervention Type
Drug
Intervention Name(s)
Infliximab at weeks 0,4, and 8
Intervention Type
Drug
Intervention Name(s)
Infliximab at weeks 0 and 8
Intervention Description
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.
Primary Outcome Measure Information:
Title
Failure Rate
Description
Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Short-term clinical response
Description
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
Title
Long-term clinical response
Description
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
Title
Short-term changes in patient Quality of Life
Description
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame
One Year
Title
Long-term changes in patient Quality of Life
Description
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame
One Year
Title
Fecal calprotectin measurements
Description
This will be measured by ELISA kits
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lea Chen
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Managing Infliximab Reinduction After Temporary Discontinuation of Drug
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