Time (weeks) | |
---|---|
Primary end point | |
Remission* without a need for additional CD-related therapy or surgery | 52 |
Secondary efficacy end points | |
Remission* and response† | 10, 52 |
Endoscopic disease activity (presence of ulcers, SES-CD) | 10, optionally 52 |
Faecal calprotectin | 10, 52 |
Height and BMI Z-scores, bone age and pubertal development | 52 |
Quality of life (IMPACT-III) | 14, 52 |
Cumulative therapy use and therapy failure | 52 |
Secondary safety end points | |
Adverse events and complications | 52 |
Long-term end points | |
Remission* without a need for additional CD-related therapy or surgery | 104, 156, 208, 260 |
Remission* and response† | 104, 156, 208, 260 |
Faecal calprotectin | 104, 156, 208, 260 |
Number of flares | 104, 156, 208, 260 |
Quality of life (IMPACT-III) | 260 |
Cumulative therapy use and therapy failure | 260 |
Adverse events and complications | 260 |
Subanalyses | |
Comparing efficacy and safety of prednisolone plus AZA with EEN plus AZA | |
Correlations between wPCDAI, faecal calprotectin and endoscopic disease severity (SES-CD) | |
Additional objectives | |
Comparing the cost-effectiveness of top-down with that of step-up | |
Identifying predictive biomarkers for treatment response | |
Assessing the pharmacokinetic and pharmacodynamic properties of IFX in children |
*Remission: wPCDAI<12.5.
†Response: wPCDAI decrease >17.5.
AZA, azathioprine; BMI, body mass index; EEN, exclusive enteral nutrition; IFX, infliximab; IMPACT-III;27 ,28 SES-CD, simplified endoscopic activity score for Crohn's disease;29 wPCDAI, weighted Paediatric Crohn's Disease Activity Index.25