Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease

NCT ID: NCT01438151

Last Updated: 2014-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to improve the investigators understanding of the relationship between Crohn's disease and blood levels of the drug infliximab (Remicade). The investigators want to determine whether measuring drug levels can be helpful in understanding how patients respond to this treatment.

Detailed Description

The efficacy of infliximab to maintain remission in Crohn's disease has been confirmed by randomized, controlled trials, however the utility of serum infliximab and ATI titers is less clearly described in the clinical practice setting to manage dose and interval levels.

The primary objective of this study is to evaluate the clinical responsiveness of active (HBI >10) Crohn's disease to infliximab as it relates to serum infliximab levels. Though the assay for an infliximab level is commercially available, current dosing practices rely on the assessment of clinical data (laboratory data, symptoms, colonoscopy, etc). In order to understand this relationship, serum infliximab and ATI titers will be collected over the course of 8 (approximately 1 year) infusions. The results of these levels will be retrospectively correlated to the patient's clinical response to treatment.

The secondary objective is to identify predictors of poor response to infliximab by evaluating the efficacy of a dose escalation strategy in patients classified as primary or secondary non-responders.

Understanding the association of serum infliximab levels to disease response may be a useful objective tool to optimize and individualize dosing amount and frequency especially in patients with incomplete or loss of response to therapy.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Remicade

Subjects will begin with receiving infliximab at 5 mg/kg for the first visits. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.

Group Type: EXPERIMENTAL

Remicade

Intervention Type: DRUG

The first potential for dose augmentation will be at infusion #3 (visit 1 and 2 patients will receive 5 mg/kg). Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.

Interventions

Remicade

The first potential for dose augmentation will be at infusion #3 (visit 1 and 2 patients will receive 5 mg/kg). Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.

Intervention Type: DRUG

Other Intervention Names

Dose escalation

Eligibility Criteria

Inclusion Criteria

• Patients with active (HBI >10) refractory inflammatory and/or perianal fistulizing Crohn's disease who are prescribed infliximab as standard of care by their gastroenterologist.

Exclusion Criteria

• Pregnant women.

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shradha Agarwal

OTHER

Sponsor Role: lead

Prometheus Laboratories

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Shradha Agarwal

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shradha Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Lloyd Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

11-0693

Identifier Type: -

Identifier Source: org_study_id