Withdrawal of INfliximab in patients with inflammatory bowel disease in remission guided by pharmacoKinetics: WINK study.
Completed
- Conditions
- Inflammatory bowel disease Ulcerative Colitis Crohn's Disease10017969
- Registration Number
- NL-OMON49879
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- Age > 18 years
- Diagnosis of IBD (Crohn*s Disease, Ulcerative colitis, IBD-U)
- Use of IFX with at >1 remaining dose scheduled after informed consent
- Clinical remission >6 months without IBD-related use of corticosteroids.
- Undetectable trough level of IFX (last available measurement)
- Endoscopic remission (SESCD<5 or eMayo<3), timeline and possible exceptions
specified in protocol.
- Informed consent
Exclusion Criteria
- No indication for additional IFX infusion in same dose and at same dosing
interval as part of routine clinical practice.
- Concomitant use of systemic steroids, ustekinumab, vedolizumab or
jak-inhibitor (tofacitinib) at the time of IFX infusion with study
measurements.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Outcome:<br /><br>descriptive: interindividual variation in pharmacokinetic parameters.<br /><br>time-to-event: Relapse rate after withdrawal of anti-TNF within one year.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Endoscopical relapse rate<br /><br>- Clinical + biochemical relapse rate<br /><br>- Occurrence of IBD related complications</p><br>