Stavanger IBD Study - Cross Sectional

Inflammatory Bowel Disease Clinical Trial

— SUSI-CS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02134054
• Other study ID #: SUSI-CS_1
• Status: Active, not recruiting
• Start date: April 2014
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: December 2024
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	Oslo University Hospital, Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	One year
Primary	Clinical remission rate	Harvey Bradshaw Index <5 Partial Mayo score <=2	One Year
Secondary	Symptom scoring	Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.	One Year
Secondary	Inflammatory markers	C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.	One year
Secondary	Fatigue scoring	Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.	One Year