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
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