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

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Remicade (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Shradha Agarwal

Official(s) and/or principal investigator(s):
Shradha Agarwal, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Lloyd Mayer, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai

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.

Clinical Details

Official title: Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease

Study design: Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Remicade Dose Escalation

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.

Eligibility

Minimum age: 7 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States
Additional Information

Starting date: December 2011
Last updated: March 4, 2014

Page last updated: August 23, 2015

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