Measuring infliximab and adalimumab blood levels in IBD patients, prospective observations from a single center compared to a time period before regular use of these measurements.
- Conditions
- Inflammatory bowel diseases, IBD, inflammatoire darm ziekten, Crohn's disease, Ziekte van Crohn, ulcerative colitis, colitis ulcerosa, IBD-U, IBD-unclassified, biologicals, TNFalpha blockers, anti-TNF-alfa, infliximab, IFX, adalimumab, ADM, therapeutic drug monitoring, TDM, trough levels, medicatiespiegels, dalspiegels.
- Registration Number
- NL-OMON29021
- Lead Sponsor
- oordwest Ziekenhuisgroep
- Brief Summary
Intentions are publication in an international peer reviewed scientific magazine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 275
For the historical cohort:
- All patients who were 18 years and older on 01-01-2016 and no longer being cared for by our paediatricians
-Any IBD-patient (who was) participating in a clinical trial for one of these biologicals that dictated/s an alternative treatment regimen than was/is used in clinical practice.
- Any IBD patient whose treatment indication for infliximab or adalimumab is/was not primarily for IBD during the study periods (such as rheumatoid arthritis or psoriasis).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To explore the proportion of patients needing rescue therapy in the form of steroids, surgery and/or discontinuation or switch of the TNF-alpha blocker due to refractory disease in a one year period
- Secondary Outcome Measures
Name Time Method