An observational study in Inflammatory Bowel Disease, sponsored by Helse Stavanger HF. Active, not recruiting at 1 site in Norway. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Helse Stavanger HF · Observational
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.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's enrollment of 210 is above the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Helse Stavanger HF is the lead sponsor of 93 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab
Exclusion Criteria:
Patients on treatment with biologics (infliximab or adalimumab)
Clinical remission rate
Harvey Bradshaw Index \<5 Partial Mayo score \<=2
Time frame: One Year
Symptom scoring
Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.
Time frame: One Year
Inflammatory markers
C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.
Time frame: One year
Fatigue scoring
Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.
Time frame: One Year
Healthcare resource utilization
Registration of * Outpatient visits * Hospital admissions (days) * Sick leave (days) * Visits at general practitioner due to IBD activity * Endoscopy due to IBD activity
Time frame: One year
Plan to share: No
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Helse Stavanger HF