Crohn's disease
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 or older - Diagnosis of colonic and/or distal ileal CD - Sustained steroid-free clinical remission for 9 months whilst being treated with adalimumab at a stable dose - Adalimumab dosed at 40 mg every 2 weeks - Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment: 1. Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician 2. Fecal calprotectin (FC) lower than 150 µg/g and CRP
Exclusion criteria
Exclusion criteria: - Absence of written informed consent - Concomitant corticosteroid usage - Need for IBD-related surgery - Actively draining peri-anal fistula - Pregnancy or lactation - Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness) - Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: The difference in cumulative incidence of persistent flares between the dose reduction and usual care groups at 48-week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes • Cumulative incidence of patients with transient flare (duration | — |
Countries
Netherlands
Outcome results
None listed