Crohn's disease
Conditions
Brief summary
The primary endpoint is the difference in number of yearly-quarters of corticosteroid free clinical and biochemical remission at week 96. Safety outcomes are disease progression at week 96, drug related adverse events and disease related serious adverse events (hospitalisations, surgery).
Detailed description
The secondary outcomes are total health care costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, drug-related side effects and patient reported outcome measures on quality of life, (work) disability and treatment-tolerability.
Interventions
Sponsors
Universiteit Maastricht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference in number of yearly-quarters of corticosteroid free clinical and biochemical remission at week 96. Safety outcomes are disease progression at week 96, drug related adverse events and disease related serious adverse events (hospitalisations, surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are total health care costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, drug-related side effects and patient reported outcome measures on quality of life, (work) disability and treatment-tolerability. | — |
Countries
Netherlands
Outcome results
None listed