Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients (X-Sectional)

University of Western Ontario, Canada

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00676988

RP0701

Details and patient eligibility

About

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.

Full 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 ).

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

327 participants in 1 patient group

Observation

Description:

Subjects with Luminal Crohn's Disease receiving infliximab