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

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

NCT01787786•University of Western Ontario, Canada

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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).

Key Dates

Primary Completion Date

March 1, 2017

Completion Date

September 1, 2017

Last Updated

December 3, 2015

Conditions

Crohn's DiseaseUlcerative Colitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis