Stavanger IBD Study - Cross Sectional (SUSI-CS)

March 14, 2024 updated by: Helse Stavanger HF

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

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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, 4068
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Biologic
Patients on treatment with biologics (infliximab or adalimumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission rate
Time Frame: One Year
Harvey Bradshaw Index <5 Partial Mayo score <=2
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom scoring
Time Frame: One Year
Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.
One Year
Inflammatory markers
Time Frame: One year
C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.
One year
Fatigue scoring
Time Frame: One Year
Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.
One Year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare resource utilization
Time Frame: One year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

Oslo University Hospital
Rikshospitalet University Hospital

Investigators

  • Principal Investigator: Tore B Grimstad, MD, PhD, Stavanger University Hospital, Department of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimated)

May 8, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUSI-CS_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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