Overview

This trial is active, not recruiting.

Condition inflammatory bowel disease
Sponsor Helse Stavanger HF
Collaborator Oslo University Hospital Rikshospitalet
Start date April 2014
End date November 2015
Trial size 210 participants
Trial identifier NCT02134054, SUSI-CS_1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients on treatment with biologics (infliximab or adalimumab)

Primary Outcomes

Measure
Clinical remission rate
time frame: One year

Secondary Outcomes

Measure
Symptom scoring
time frame: One year
Inflammatory markers
time frame: One year
Fatigue scoring
time frame: One year

Eligibility Criteria

Male or female participants at least 16 years old.

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.

Additional Information

Official title Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics
Principal investigator Tore B Grimstad, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Helse Stavanger HF.