Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease Adalimumab
Conditions
Interventions
Intervention: adalimumab 40mg every 21 days
Control: adalimumab 40mg every 14 days
Sponsors
Erasmus MC
Eligibility
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 < 200 ìg/g and CRP within normal range -Full endoscopic remission (no ulcera) assessed at least within 12 months before inclusion Permitted concomitant therapy: aminosalicylates, azathioprine, 6-mercatopurine and methotrexate at stable dose for 12 weeks
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 |
|---|---|
| Number of patients in remission, 24 weeks after dose adjustment of adalimumab | — |
Secondary
| Measure | Time frame |
|---|---|
| -Relapse rates in both groups, defined by increase of fecal calprotectin and/or CRP and clinical activity, and subsequently confirmed by endoscopy -Tolerability | — |
Contacts
Public ContactM. Lie
Erasmus MC Postbus 2040
Outcome results
None listed