Crohn's Disease, Ulcerative Colitis
Conditions
Keywords
Crohn's Disease, Ulcerative Colitis, Optimal Use of infliximab
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.
Interventions
None listed
Sponsors
University of Western Ontario, Canada
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Quantification of relative strengths of individual determinants of infliximab pharmacokinetics | 24 weeks | Assessment of potential interactions between these determinants. |
Other
| Measure | Time frame |
|---|---|
| Identification of patients at baseline that would benefit from receiving higher does of infliximab due to accelerated drug clearance | 24 weeks |
Outcome results
None listed