Predicting trough levels in patients receiving infliximab maintenance therapy using interval (non-trough) serum infliximab levels
Completed
- Conditions
- Crohn's disease10017969enteritis regionalis
- Registration Number
- NL-OMON41068
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- Age *18 years
- Crohn*s disease based on endoscopy and pathology
- Clinical remission based on a Harvey Bradshaw Index score of <5
- Biochemical remission based on fecal calprotectin levels of <250µg/g
- Scheduled IFX maintenance therapy with 5mg/kg body weight every 8 weeks
Exclusion Criteria
- Change in immunomodulator co-treatment within the previous 3 months
- Previous non-adherence to the 8-week infusion schedule
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Serum infliximab level at week 0, 4, 6 and 8.</p><br>
- Secondary Outcome Measures
Name Time Method <p>CRP, albumin</p><br>