Managing Infliximab Reinduction After Temporary Discontinuation of Drug

Inflammatory Bowel Disease Clinical Trial

Official title:

Managing Infliximab Reinduction After Temporary Discontinuation of Drug

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02771457
• Other study ID #: 15-01180
• Status: Withdrawn
• Phase: Phase 3
• First received: May 9, 2016
• Last updated: June 29, 2016
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: June 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Infliximab at weeks 0,2, and 6

• Infliximab at weeks 0,4, and 8

• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure Rate	Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.	One year	No
Secondary	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.	One year	No
Secondary	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.	One year	No
Secondary	Short-term changes in patient Quality of Life	This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	One Year	No
Secondary	Long-term changes in patient Quality of Life	This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	One Year	No
Secondary	Fecal calprotectin measurements	This will be measured by ELISA kits	One year	No