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Disease Course in an IBD Cohort in the Era of Biological Treatment

NCT01468090 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 192

Last updated 2014-09-16

No results posted yet for this study

Summary

The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562 adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort is established after the implementation of biological agents in the treatment of IBD and the investigators hypothesis is that a) Severe disease course in IBD can be predicted by phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to be used as guidance in the selection of treatment strategy and b) Introduction of biological treatment changes the course of disease in IBD and reduces the need of surgical procedures.

Methods: Medical records will be reviewed to register the use of medication, flare ups (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior will be evaluated. At outpatient visits patients will get a clinical examination, blood and faeces will be collected to biobank and patients will be offered an endoscopical examination. The Montreal classification, The Harvey \& Bradshaw's activity index (CD) and the SCAAI score (UC) will be used to describe disease localization, extent, behavior and severity. An electronic database will be established in use of processing data.

Conditions

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Marianne Vester-Andersen, MD · Dep. of Gastroenterology 360, Hvidovre Hospital

  • Pia Munkholm, MD, DMsc · Dep. of Gastroenterology, Herlev Hospital

  • Ida Vind, MD, PhD · Dep. of gastroenterology, Amager Hospital

  • Flemming Bendtsen, prof. DMsci · Gastroenheden 360 Hvidovre University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Denmark

Study Locations

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Diseases
Companies

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 NCT01468090 on ClinicalTrials.gov