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OpenTrials
Completed

NCT Number: NCT01468090

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital, Gastroenheden 360, Hvidovre, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients wil be followed up and diagnosis will be reassessed.

Exclusion criteria

  • Non-IBD (after reassessing diagnosis)

Treatment and study plan

Primary outcomes

  1. Surgical rate

    Time frame: 7 years from inception (2003-04)

    The risk of intestinal surgery from inception (2003-04) until 7 years of follow-up in Crohn's disease and ulcerative colitis

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Ferring Pharmaceuticals
  • Merck Sharp & Dohme LLC

Registry information

Official study title

Risk of Surgery Among Patients Wih Ulcerative Colitis and Croh'ns Disease After Seven Years of Follow-up in the Era of Biological Treatment.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 9, 2011
Registry last updated
Sep 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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