Stavanger IBD Study - Cross Sectional
- Conditions
- Inflammatory Bowel Disease
- Registration Number
- NCT02134054
- Lead Sponsor
- Helse Stavanger HF
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 210
- Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)
- Inability to consent
- Inability to adhere to treatment protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical remission rate One Year Harvey Bradshaw Index \<5 Partial Mayo score \<=2
- Secondary Outcome Measures
Name Time Method Inflammatory markers One year C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.
Symptom scoring One Year Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.
Fatigue scoring One Year Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.
Trial Locations
- Locations (1)
Stavanger University Hospital
🇳🇴Stavanger, Norway