Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients

Crohn's Disease Clinical Trial

— X-Sectional  

Official title:

A Cross Sectional Study To Determine The Relationship Between Serum Infliximab Concentration And Efficacy In Patients With Luminal Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676988
• Other study ID #: RP0701
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: June 13, 2012
• Start date: May 2008
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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 ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
Canada	MedEmerg Infusion Clinics	Mississauga	Ontario
Canada	CIM - Centre d'Intervention Medicales Inc.	Pointe-Claire	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Schering-Plough

Country where clinical trial is conducted

Canada,