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Managing Infliximab Reinduction After Temporary Discontinuation of Drug

NCT ID: NCT02771457

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Keywords

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Influximab IFX Remicade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infliximab at weeks 0,2, and 6

In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.

Group Type EXPERIMENTAL

Infliximab at weeks 0,2, and 6

Intervention Type DRUG

Infliximab at weeks 0,4, and 8

In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8

Group Type EXPERIMENTAL

Infliximab at weeks 0,4, and 8

Intervention Type DRUG

Infliximab at weeks 0, and 8

In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8.

Group Type ACTIVE_COMPARATOR

Infliximab at weeks 0 and 8

Intervention Type DRUG

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.

Interventions

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Infliximab at weeks 0,2, and 6

Intervention Type DRUG

Infliximab at weeks 0,4, and 8

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lea Chen

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Other Identifiers

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15-01180

Identifier Type: -

Identifier Source: org_study_id