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Increasing time between adalimumab injections in IBD patients.


- candidate number16292
- NTR NumberNTR4566
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jan-2014
- Secondary IDs
- Public TitleIncreasing time between adalimumab injections in IBD patients.
- Scientific TitleLengthening Adalimumab Dosing Interval in IBD patients in long term remission, the LADI study.
- ACRONYMLADI study.
- hypothesisPrevious 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.
- Healt Condition(s) or Problem(s) studiedUlcerative Colitis, Crohn's disease, IBD, Inflammatory bowel disease
- Inclusion criteriaAge 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 criteriaConcomitant 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)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2015
- Target number of participants72
- InterventionsIntervention: adalimumab 40mg every 21 days Control: adalimumab 40mg every 14 days
- Primary outcomeNumber of patients in remission, 24 weeks after dose adjustment of adalimumab
- Secondary outcome-Relapse rates in both groups, defined by increase of fecal calprotectin and/or CRP and clinical activity, and subsequently confirmed by endoscopy
-Tolerability
- TimepointsStudy duration per patient: 24 weeks
Follow-up visits every 6 weeks.
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Lie
- CONTACT for SCIENTIFIC QUERIESDr. C.J. Woude, van der
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications-
- Brief summarySingle 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.
- Main changes (audit trail)
- RECORD30-jan-2014 - 1-jun-2014


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