Clinical Validation of a Point of Care (POC) Test for the Measurement of Infliximab (IFX) or Adalimumab (ADL) Levels in the Serum of Inflammatory Bowel Disease (IBD) Patients
- Conditions
- inflammatory bowel disease
- Registration Number
- NL-OMON20824
- Lead Sponsor
- ProciseDx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
1.Adult (=16 years old) Males and females with either CD or UC.
2.Patients must have a confirmed diagnosis of CD or UC based on results of a complete medical evaluation and assessment by a physician specialized in inflammatory bowel disease.
3.Patients must be undergoing maintenance phase IFX or ADL therapy at the time of the first blood collection used for the current study
4.Patients must have at least 24 months of follow up after the baseline sample.
5.Written informed consent must be provided.
1.Patients not undergoing maintenance phase IFX, ADL or biosimilar therapy at time of baseline sample collection.
2.Patients not diagnosed with either CD or UC.
3.Receipt of any blood products within 3 months prior to the baseline sample collection
4.Participation in a clinical trial at the baseline sample collection or within the 8 weeks prior to the baseline sample collection.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients developing Loss of Response (LOR) to IFX or ADL.<br><br>Loss of response is a composite endpoint defined as:<br>1)Stopping IFX or ADL therapy due to worsening symptoms and abnormal endoscopy/imaging/biomarker indicating increased disease activity or<br>2)Need for addition of corticosteroids, and/or addition immunomodulators (thiopurines or methotrexate), and/or addition of a second biologic due to worsening symptoms and abnormal endoscopy/biomarker results indicating increased disease activity or<br>3)Increase in fecal calprotectin concentration of =100 mg/Gr to a value >250mg/Gr<br>4)Need for surgery (intestinal resection, fistulotomy, stricturoplasty) due to IBD exacerbation or<br>5)New or recurring actively-draining fistula or<br>6)Endoscopic deterioration compared to previous endoscopy – both performed during anti-TNF maintenance treatment – defined by a total SES CD score increase of =50% or endoscopic mayo score increase =1<br>
- Secondary Outcome Measures
Name Time Method Time to Loss of Response (LOR) to IFX or ADL<br>Proportion of patients undergoing treatment optimization using a dose intensification and/or interval decrease/increase.