Inflammatory bowel disease
Conditions
Interventions
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Solution for injection in pre-filled pen
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 or older Written informed consent. Previous diagnosis of ileocolonic Crohn's disease or ulcerative colitis In sustained clinical remission for at least 6 months whilst being treated with adalimumab Adalimumab dosed at 40mg, once every 2 weeks Full clinical response and disease control, defined as -Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician -Fecal calprotectin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concomitant corticosteroid usage Imminent need for IBD-related surgery Actively draining perianal fistula Pregnancy or lactation Other significant medical illness that might interfere with this study (such as current malignancy, immunodeficiency syndromes and psychiatric illness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of lengthening the adalimumab dosing interval from 2 to 3 weeks, in patients with Crohn's disease or ulcerative colitis in long term (6 months) remission.;Secondary Objective: Not applicable;Primary end point(s): No change in HBI and SCCAI scores (non-inferiority). Non inferiority in fecal calprotectin levels.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Relapse rates in both groups, defined by increase of fecal calprotectin and/or CRP and clinical activity, and subsequently confirmed by endoscopy -Tolerability -Effect of dose adjustment on quality of life and adherence to therapy -Cost effectiveness of dose lengthening;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
Netherlands
Contacts
Public ContactJanneke van der Woude
Erasmus MC
Outcome results
None listed