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

This study has been terminated.
(terminated due to poor enrollment)
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Shradha Agarwal, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01438151
First received: September 20, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Crohn's Disease
Drug: Remicade

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Remicade Dose Escalation [ Time Frame: 2/16/12-3/22/13 ] [ Designated as safety issue: No ]
    At visit 1 and 2, Remicade given at 5mg/kg. 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.


Enrollment: 11
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: 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

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438151

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Shradha Agarwal
Prometheus Laboratories
Investigators
Principal Investigator: Shradha Agarwal, MD Mount Sinai School of Medicine
Principal Investigator: Lloyd Mayer, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Shradha Agarwal, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01438151     History of Changes
Other Study ID Numbers: 11-0693
Study First Received: September 20, 2011
Results First Received: January 6, 2014
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Crohn's disease
Remicade
infliximab

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014