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Clinical Trials/NCT02134054
NCT02134054Active, not recruitingNot Applicable

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

Helse Stavanger HF1 site in 1 country210 target enrollmentStarted: April 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
210
Locations
1
Primary Endpoint
Clinical remission rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Clinical remission rate

Time Frame: One Year

Harvey Bradshaw Index \<5 Partial Mayo score \<=2

Secondary Outcomes

  • Inflammatory markers(One year)
  • Symptom scoring(One Year)
  • Fatigue scoring(One Year)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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