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

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

Detailed Description
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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.

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

Conditions
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Crohn's Disease, Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Irritable Bowel Disease<br>Infliximab administered according to current FDA and EMS approved doses and intervals. | |

What is the study measuring?
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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 | 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 | Assessment of potential interactions between these determinants. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Ulcerative Colitis, Optimal Use of infliximab