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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20824

Enrollment

320

Registered

2020-09-14

Start date

2020-09-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

Measure	Time frame
Time to Loss of Response (LOR) to IFX or ADL Proportion of patients undergoing treatment optimization using a dose intensification and/or interval decrease/increase.	—

Primary

Measure	Time frame
Proportion of patients developing Loss of Response (LOR) to IFX or ADL. Loss of response is a composite endpoint defined as: 1)Stopping IFX or ADL therapy due to worsening symptoms and abnormal endoscopy/imaging/biomarker indicating increased disease activity or 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 3)Increase in fecal calprotectin concentration of =100 mg/Gr to a value >250mg/Gr 4)Need for surgery (intestinal resection, fistulotomy, stricturoplasty) due to IBD exacerbation or 5)New or recurring actively-draining fistula or 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	—

Measure

Time frame

Proportion of patients developing Loss of Response (LOR) to IFX or ADL. Loss of response is a composite endpoint defined as: 1)Stopping IFX or ADL therapy due to worsening symptoms and abnormal endoscopy/imaging/biomarker indicating increased disease activity or 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 3)Increase in fecal calprotectin concentration of =100 mg/Gr to a value >250mg/Gr 4)Need for surgery (intestinal resection, fistulotomy, stricturoplasty) due to IBD exacerbation or 5)New or recurring actively-draining fistula or 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

—

Contacts

Public ContactToer Stevens

Amsterdam UMC, location AMC

t.w.stevens@amc.uva.nl0205665584

Outcome results