Status:
COMPLETED
Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients
Lead Sponsor:
University of Western Ontario, Canada
Collaborating Sponsors:
Schering-Plough
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
- Active draining fistulizing Crohn's Disease
- Presence of an ostomy
- Diagnosis of ulcerative colitis
- Infliximab dose of \>5mg/kg
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT00676988
Start Date
May 1 2008
End Date
April 1 2011
Last Update
June 14 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
MedEmerg Infusion Clinics
Mississauga, Ontario, Canada, L5N 2W3
2
CIM - Centre d'Intervention Medicales Inc.
Pointe-Claire, Quebec, Canada, H9R 4S2