Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients
X-Sectional
A Cross Sectional Study To Determine The Relationship Between Serum Infliximab Concentration And Efficacy In Patients With Luminal Crohn's Disease
1 other identifier
observational
327
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 14, 2012
June 1, 2012
2.9 years
May 8, 2008
June 13, 2012
Conditions
Keywords
Study Arms (1)
Observation
Subjects with Luminal Crohn's Disease receiving infliximab
Eligibility Criteria
Subjects with Luminal Crohn's disease receiving infliximab at Canadian Infusion Centres
You may qualify if:
- 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
You may not qualify if:
- Active draining fistulizing Crohn's Disease
- Presence of an ostomy
- Diagnosis of ulcerative colitis
- Infliximab dose of \>5mg/kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Western Ontario, Canadalead
- Schering-Ploughcollaborator
Study Sites (2)
MedEmerg Infusion Clinics
Mississauga, Ontario, L5N 2W3, Canada
CIM - Centre d'Intervention Medicales Inc.
Pointe-Claire, Quebec, H9R 4S2, Canada
Related Publications (1)
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.
PMID: 24689499DERIVED
Biospecimen
Serum infliximab concentrations and CRP levels.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian G Feagan, MD
Director Clinical Trials
- PRINCIPAL INVESTIGATOR
Gordon R Greenberg, MD
co-principal investigator
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2008
First Posted
May 13, 2008
Study Start
May 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 14, 2012
Record last verified: 2012-06