Previous studies have shown that the half life of adalimumab increases to up to 21 days, after several doses have been administered. As such it seems possible to increase the dosing interval from 14 days to 21 days, in patients IBD in long term…
ID
Bron
Verkorte titel
Aandoening
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Adalimumab
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of patients in remission, 24 weeks after dose adjustment of adalimumab
Achtergrond van het onderzoek
Single center, randomized, controlled, open label trial with two treatment arms.
Rationale:
Healthcare costs in IBD are mainly driven by medication costs, with anti-TNF alfa
therapies making up the bulk of these costs. If it is possible to safely lengthen the
adalimumab dosing interval from 2 weeks to 3 weeks, this would result in significant
reduction of medication and total healthcare costs.
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.
Doel van het onderzoek
Previous studies have shown that the half life of adalimumab increases to up to 21 days, after several doses have been administered.
As such it seems possible to increase the dosing interval from 14 days to 21 days, in patients IBD in long term remission.
Onderzoeksopzet
Study duration per patient: 24 weeks
Follow-up visits every 6 weeks.
Onderzoeksproduct en/of interventie
Intervention: adalimumab 40mg every 21 days
Control: adalimumab 40mg every 14 days
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4443 |
| NTR-old | NTR4566 |
| Ander register | : - |