Stavanger IBD Study - Cross Sectional

NCT02134054 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Rikshospitalet University Hospital

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Tore B Grimstad, MD, PhD · Stavanger University Hospital, Department of Medicine

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-11-30
Completion
2024-12-31

Countries

  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134054 on ClinicalTrials.gov