Dose reduction of infliximab in Crohn's disease, based on serum infliximab concentration.
Suspended
- Conditions
- Crohn's diseaseZiekte van Crohn
- Registration Number
- NL-OMON22458
- Lead Sponsor
- Academic Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 54
Inclusion Criteria
1. Diagnosis of CD based on endoscopy and pathology;
2. 18 years or older;
Exclusion Criteria
1. Non-adherence to the 8 weekly infusions schedule in the past;
2. Participation in another therapeutic trial;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with sustained clinical remission
- Secondary Outcome Measures
Name Time Method 1.Quality of life <br /><br>2.Economic evaluation and pharmacoeconomic evaluation (yearly costs of IFX per QALY)<br /><br>3.Incidence and severity of adverse events / side effects<br /><br>4.Proportion of patients in clinical remission (additional analyses)<br /><br>5. Proportion of patients in biochemical remission<br /> <br>6.Proportion of patients in sustained clinical remission <br /><br>7.Proportion of patients in sustained biochemical remission<br /><br>8.Time to clinical relapse<br /><br>9.Time to biochemical relapse<br /><br>10.Presence of predictive factors for successful IFX dose reduction (with specific focus on smoking status, body mass index and extent of disease)<br /><br>11.Yearly total IFX dose per person<br>