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

Withdrawn

• Conditions: Ulcerative Colitis; Crohn's Disease

• Registration Number: NCT01787786
• Lead Sponsor: University of Western Ontario, Canada

Brief 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.

Study Timeline

• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease	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.

Secondary Outcome Measures

Name	Time	Method
Quantification of relative strengths of individual determinants of infliximab pharmacokinetics	24 weeks	Assessment of potential interactions between these determinants.