Stavanger IBD Study - Cross Sectional (SUSI-CS)
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|ClinicalTrials.gov Identifier: NCT02134054|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2014
Last Update Posted : February 5, 2020
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.
|Condition or disease|
|Inflammatory Bowel Disease|
|Study Type :||Observational|
|Actual Enrollment :||210 participants|
|Official Title:||Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||December 2021|
Patients on treatment with biologics (infliximab or adalimumab)
- Clinical remission rate [ Time Frame: One Year ]Harvey Bradshaw Index <5 Partial Mayo score <=2
- Symptom scoring [ Time Frame: One Year ]Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.
- Inflammatory markers [ Time Frame: One year ]C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.
- Fatigue scoring [ Time Frame: One Year ]Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.
- Healthcare resource utilization [ Time Frame: One year ]
- Outpatient visits
- Hospital admissions (days)
- Sick leave (days)
- Visits at general practitioner due to IBD activity
- Endoscopy due to IBD activity
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134054
|Stavanger University Hospital|
|Stavanger, Norway, 4068|
|Principal Investigator:||Tore B Grimstad, MD, PhD||Stavanger University Hospital, Department of Medicine|