Crohn's Disease Inflammatory Bowel Disease
Conditions
Interventions
Cessation of anti-TNF therapy (only in patients who participate in Stage 2 of
the trial).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Luminal CD as indication for anti-TNF therapy - Clinical remission (HBI = 12 months and a stable dose >= 3 months - Relapse risk
Exclusion criteria
Exclusion criteria: - Ulcerative colitis or IBD-unclassified. - Co-morbidities that are a contraindication for (dis)continuing anti-TNF therapy (such as rheumatic diseases or perianal fistula) - Corticosteroid use 6 months prior to inclusion - Malignancy (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is a documented relapse of CD or CD complications that necessitates (re)introduction of biologicals, corticosteroids, immunosuppressants, antibiotics, or surgery for Crohn*s Disease complications. A documented relapse of CD is defined as a clinical relapse (HBI >= 5) in combination with faecal calprotectin > 250 µg/g and/or endoscopic ulcerations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of remission; time to relapse; sustained low-risk for relapse; quality of Life: IBD-Q and EQ-5D; work productivity; total costs: drug costs, other health care costs (iMCQ) and productivity loss (iPCQ); costeffectiveness analysis after 1 and 2 years. | — |
Countries
Netherlands
Outcome results
None listed