Improving Treatment of Inflammatory Bowel Diseases Through Better Understanding Infliximab Drug and Antibody Levels (OPTIMIZE)

December 1, 2015 updated by: University of Western Ontario, Canada

Defining and Predicting the Ideal Infliximab Pharmacokinetic Profile Associated With Treatment Efficacy in Patients With Inflammatory Bowel Disease

The purpose of this study is to develop a predictive model that will allow optimized dosing of infliximab for individual patients

Study Overview

Status

Withdrawn

Conditions

Detailed Description

The use of pharmacokinetic analyses incorporating relevant determinants of the infliximab serum concentration can be used to develop a predictive model that will allow optimized dosing for individual patients.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 patients with Crohn's Disease and 50 patients with Ulcerative Colitis from 10 centres (Canada, United States, Netherlands and Spain).

Description

Inclusion Criteria:

  • a diagnosis of CD or UC by usual criteria,
  • moderate to severely active CD defined by a CDAI ≥ 220, with confirmed endoscopic activity (CDEIS ≥ 6) or moderate to severely active UC, defined by a Mayo Score ≥ 6, with a Mayo endoscopic subscore ≥ 2,
  • a need for treatment with IFX for induction of remission as clinically indicated
  • patients previously exposed to adalimumab and/or certolizumab who are naïve to infliximab will be allowed to participate.

Exclusion Criteria:

  • perianal CD exclusively
  • disease limited to the rectum in patients with UC (i.e., disease must extend ≥ 15 cm from the anal verge)
  • patients with known antibodies to IFX (ADAs) at baseline
  • a contraindication to infliximab therapy
  • a contraindication to endoscopy
  • an ostomy
  • planned surgery
  • evidence of severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease at the discretion of the investigator,
  • Pregnancy or breastfeeding,
  • treatment with any investigational drug in the past 30 days, or 5 half lives (whichever is longer).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Irritable Bowel Disease
Infliximab administered according to current FDA and EMS approved doses and intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease
Time Frame: 24 weeks
The primary objective of this study is to define the PK profile of IFX in patients with CD and UC and to determine covariates influencing drug clearance.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of relative strengths of individual determinants of infliximab pharmacokinetics
Time Frame: 24 weeks
Assessment of potential interactions between these determinants.
24 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Identification of patients at baseline that would benefit from receiving higher does of infliximab due to accelerated drug clearance
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Brian Feagan, MD, Robarts Clinical Trials - Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP1207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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