Crohn's disease Ziekte van Crohn
Conditions
Interventions
Patients in the intervention arm will undergo stepwise dose reduction of IFX. IFX dose will be decreased by 1 mg/kg per step. The dose reduction phase ends in case of relapse and/or if trough levels d
g/ml.
Patients in the control arm will receive continued IFX at 5 mg/kg at an 8 week interval.
Sponsors
Academic Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of CD based on endoscopy and pathology; 2. 18 years or older; 3. At least 6 months in remission, defined as: A. Harvey Bradshaw Index score ≤4; B. Normal serum C-reactive protein (CRP) level ( 6 months at 5 mg/kg every 8 weeks with or without concomitant immunosuppression; 5. IFX TL > 7 ug/ml.
Exclusion criteria
Exclusion criteria: 1. Non-adherence to the 8 weekly infusions schedule in the past; 2. Participation in another therapeutic trial; 3. Prior dose adjustments or interval shortening of IFX; 4. In case of immunosuppression: start < 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with sustained clinical remission | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life 2. Economic evaluation and pharmacoeconomic evaluation (yearly costs of IFX per QALY) 3. Incidence and severity of adverse events / side effects 4. Proportion of patients in clinical remission (additional analyses) 5. Proportion of patients in biochemical remission 6. Proportion of patients in sustained clinical remission 7. Proportion of patients in sustained biochemical remission 8. Time to clinical relapse 9. Time to biochemical relapse 10. Presence of predictive factors for successful IFX dose reduction (with specific focus on smoking status, body mass index and extent of disease) 11. Yearly total IFX dose per person | — |
Contacts
Public ContactM. Löwenberg
Academic Medical Center Department of Gastroenterology and Hepatology Meibergdreef 9
Outcome results
None listed