Stavanger IBD Study - Cross Sectional

Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02134054

Acronym

SUSI-CS

Enrollment

210

Registered

2014-05-08

Start date

2014-04-30

Completion date

2024-12-31

Last updated

2024-03-15

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

Conditions

Inflammatory Bowel Disease

Keywords

Therapeutic drug monitoring, Biological treatment, IBD

Brief summary

In this cross sectional and longitudinal study, patients with inflammatory bowel disease on biological treatment with infliximab or adalimumab will be included. After inclusion, the dosage of their existing biological therapy will be adjusted following regular trough-level and antibody-level monitoring, according to a treatment algorithm. Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis is that therapeutic drug monitoring may improve clinical disease outcome after one year of follow-up.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)

Exclusion criteria

* Inability to consent * Inability to adhere to treatment protocol.

Design outcomes

Primary

Measure	Time frame	Description
Clinical remission rate	One Year	Harvey Bradshaw Index \<5 Partial Mayo score \<=2

Secondary

Measure	Time frame	Description
Symptom scoring	One Year	Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.
Inflammatory markers	One year	C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.
Fatigue scoring	One Year	Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.

Other

Measure	Time frame	Description
Healthcare resource utilization	One year	Registration of * Outpatient visits * Hospital admissions (days) * Sick leave (days) * Visits at general practitioner due to IBD activity * Endoscopy due to IBD activity

Countries

Norway

Outcome results