Managing Infliximab Reinduction After Temporary Discontinuation of Drug

Phase 3

Withdrawn

• Conditions: Inflammatory Bowel Disease
• Interventions: Drug: Infliximab at weeks 0,2, and 6; Drug: Infliximab at weeks 0,4, and 8; Drug: Infliximab at weeks 0 and 8

• Registration Number: NCT02771457
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-13
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30
• Study Start: 2016-07
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infliximab at weeks 0,2, and 6	Infliximab at weeks 0,2, and 6	In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.
Infliximab at weeks 0,4, and 8	Infliximab at weeks 0,4, and 8	In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8
Infliximab at weeks 0, and 8	Infliximab at weeks 0 and 8	In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8.

Primary Outcome Measures

Name	Time	Method
Failure Rate	One year	Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.

Secondary Outcome Measures

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