Managing Infliximab Reinduction After Temporary Discontinuation of Drug

NCT02771457 | Withdrawn Phase 3

• 1 other identifier: 15-01180
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Disease

Keywords

Influximab; IFX; Remicade

Outcome Measures

Primary Outcomes (1)

• Failure Rate

  Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.

  One year

Secondary Outcomes (5)

• Short-term clinical response

  One year

• Long-term clinical response

  One year

• Short-term changes in patient Quality of Life

  One Year

• Long-term changes in patient Quality of Life

  One Year

• Fecal calprotectin measurements

  One year

Study Arms (3)

Infliximab at weeks 0,2, and 6

EXPERIMENTAL

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

Infliximab at weeks 0,4, and 8

EXPERIMENTAL

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

Infliximab at weeks 0, and 8

ACTIVE COMPARATOR

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

Interventions

Infliximab at weeks 0,2, and 6 DRUG

Infliximab at weeks 0,2, and 6

Infliximab at weeks 0,4, and 8 DRUG

Infliximab at weeks 0,4, and 8

Infliximab at weeks 0 and 8 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.

Infliximab at weeks 0, and 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Lea Chen

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 13, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 30, 2016

Record last verified: 2016-06