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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

327 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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 ).

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observation

Subjects with Luminal Crohn's Disease receiving infliximab

No interventions assigned to this group

Eligibility Criteria

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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