Crohn's disease MedDRA version: 16.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of CD based on endoscopy and pathology -18 years or older -At least 6 months in remission, defined as a Harvey Bradshaw Index (HBI) score of =4 -IFX therapy > 6 months at 5 mg/kg every 8 weeks with or without concomitant immunosuppression (stable for > 3 months). -IFX TL > 7 ug/ml. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 224 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Non-adherence to the 8 weekly infusions schedule in the past -Participation in another therapeutic trial -Pregnancy -Prior dose adjustments or interval shortening of IFX
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of IFX dose reduction guided by serial TL measurements, compared with usual care (no dose adjustments). ;Secondary Objective: Compare the time to relapse To identify predictors allowing selection of patients in whom dose reduction is easier and more successful using a logistic regression analysis Compare laboratory tests (CRP and fecal calprotectin) at all study visits Compare adverse events To investigate whether gradual dose reduction results in a significant reduction of the per patient annual cost of IFX maintenance treatment Pharmaco-economic evaluation;Primary end point(s): Proportion of patients with sustained clinical remission;Timepoint(s) of evaluation of this end point: 24 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with clinical and biochemical relapse; Time to relapse; Presence of predictive factors for successful dose reduction with specific focus on smoking status, body mass index and extent of disease; Laboratory tests (CRP and fecal calprotectin) at all study visits; Adverse events; Yearly cost of IFX treatment in the intervention versus the control group; Pharmaco-economic evaluation.;Timepoint(s) of evaluation of this end point: 24 months after randomization | — |
Countries
Netherlands
Contacts
Public ContactMark Löwenberg
Academic Medical Center
Outcome results
None listed