Clinical trial NCT00676988: Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients
Official title: A Cross Sectional Study To Determine The Relationship Between Serum Infliximab Concentration And Efficacy In Patients With Luminal Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Luminal Crohn's Disease
Infliximab
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2008-05-13
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Luminal Crohn's disease receiving infliximab at Canadian Infusion Centres

Brief summary: To assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores and trough serum infliximab concentration in subjects who are scheduled to receive infliximab infusions at an interval of 8 weeks.

Detailed description: This cross sectional study will evaluate a sample of 360 subjects with luminal Crohn's disease who are receiving infliximab in 15-20 Canadian infusion centres. The sample will be stratified by disease activity \[mild = CDAI \<150, moderate/severe = CDAI ≥150\] and whether or not subjects are on concomitant immunosuppressive therapy. Thus 4 strata will be created consisting of 90 subjects each. Consent will be obtained prior to or at Visit 1, subjects will retrospectively complete a CDAI diary card for the preceding 7 days and blood work will be drawn prior to infliximab infusion. Four weeks thereafter at Visit 2, subjects will provide an additional blood sample to measure serum infliximab concentrations and CRP levels. Between Visits 1 and 3, subjects will complete daily CDAI diary entries. Visit 3 will take place at the next scheduled infusion, 8 weeks after Visit 1 (+/- 7 days ).

Eligibility criteria: Inclusion Criteria:

* Adult subjects (18 years of age or older at time of consent)
* Confirmed diagnosis of inflammatory luminal Crohn's Disease
* Receive infliximab therapy and have received a minimum of 5 consecutive infusions at prescribed intervals (minimum of 24 weeks and maximum of 156 weeks on infliximab therapy)
* Plan to receive the next 2 infliximab infusions at 8-weekly intervals (+/- 7 days)
* Able to provide written consent

Exclusion Criteria:

* Active draining fistulizing Crohn's Disease
* Presence of an ostomy
* Diagnosis of ulcerative colitis
* Infliximab dose of \>5mg/kg

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: MedEmerg Infusion Clinics
state: Ontario
city: Pointe-Claire
country: Canada
facility: CIM - Centre d'Intervention Medicales Inc.
state: Quebec
Study officials:
affiliation: Director Clinical Trials
name: Brian G Feagan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: co-principal investigator
name: Gordon R Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levesque BG, Greenberg GR, Zou G, Sandborn WJ, Singh S, Hauenstein S, Ohrmund L, Wong CJ, Stitt LW, Shackelton LM, King D, Lockton S, Ducharme J, Feagan BG. A prospective cohort study to determine the relationship between serum infliximab concentration and efficacy in patients with luminal Crohn's disease. Aliment Pharmacol Ther. 2014 May;39(10):1126-35. doi: 10.1111/apt.12733. Epub 2014 Apr 1.