Inflammatory Bowel Disease
Conditions
Brief summary
The primary composite endpoint is the frequency of IFX discontinuation, due to treatment failure or adverse events, or need for treatment intensification due to non-response or LOR during the first year of treatment.
Detailed description
The cumulative probability of IFX discontinuation, The cumulative probability of LOR, Subtherapeutic IFX concentrations,, Occurrence of ATI, Occurrence of infusion reactions, Endoscopic remission at 54 weeks, Treatment response at the end of induction between 12-14 weeks, Clinical remission at week 14, Clinical and biochemical remission at week 14
Interventions
DRUGINFLIXIMAB
Sponsors
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary composite endpoint is the frequency of IFX discontinuation, due to treatment failure or adverse events, or need for treatment intensification due to non-response or LOR during the first year of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative probability of IFX discontinuation, The cumulative probability of LOR, Subtherapeutic IFX concentrations,, Occurrence of ATI, Occurrence of infusion reactions, Endoscopic remission at 54 weeks, Treatment response at the end of induction between 12-14 weeks, Clinical remission at week 14, Clinical and biochemical remission at week 14 | — |
Countries
Italy
Outcome results
None listed