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Validation of a finger prick capillary blood sampling test for home monitoring of C-reactive protein and therapeutic drug monitoring of biological therapy in patients with inflammatory bowel disease

Validation of a finger prick capillary blood sampling test for home monitoring of C-reactive protein and therapeutic drug monitoring of biological therapy in patients with inflammatory bowel disease - FiP-HOME-IBD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51794
Enrollment
64
Registered
2022-04-11
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Chronic bowel disease Inflammatory bowel disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - An established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) - Receiving biological induction or maintenance therapy according to standard treatment protocols - 18 years of age or older - Written and signed informed consent

Exclusion criteria

Exclusion criteria: - Patients with a visual, physical or mental impairment, rendering them unable to use a capillary sampling device. - Patients unable to read or understand the Dutch language - Patients with severe Raynaud*s syndrome or digital ischemia - Unwillingness to participate in the study

Design outcomes

Primary

MeasureTime frame
Concentrations of CRP and pharmacodynamic and pharmacokinetic domains of biological therapy (i.e., concentration of biological trough levels, concentration of antidrug antibody levels) measured in capillary samples compared to venous samples (standard procedure)

Secondary

MeasureTime frame
-Percentage of patients unable to provide a capillary sample -Patience experience of capillary sampling through finger prick at home, invistigated through a survey

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)