Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients (X-Sectional)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||A Cross Sectional Study To Determine The Relationship Between Serum Infliximab Concentration And Efficacy In Patients With Luminal Crohn's Disease|
Serum infliximab concentrations and CRP levels.
|Study Start Date:||May 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Subjects with Luminal Crohn's Disease receiving infliximab
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 ).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676988
|MedEmerg Infusion Clinics|
|Mississauga, Ontario, Canada, L5N 2W3|
|CIM - Centre d'Intervention Medicales Inc.|
|Pointe-Claire, Quebec, Canada, H9R 4S2|
|Principal Investigator:||Brian G Feagan, MD||Director Clinical Trials|
|Principal Investigator:||Gordon R Greenberg, MD||co-principal investigator|