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

NCT01438151 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-04-09

Study results available
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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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Prometheus Laboratories

    collaborator INDUSTRY

  • Shradha Agarwal

    lead OTHER

Principal Investigators

  • Shradha Agarwal, MD · Icahn School of Medicine at Mount Sinai

  • Lloyd Mayer, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438151 on ClinicalTrials.gov