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

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis

• Registration Number: NCT01468090
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

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

Exclusion Criteria

• Non-IBD (after reassessing diagnosis)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical rate	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

Trial Locations

Locations (2)

Hvidovre Hospital, Gastroenheden 360; 🇩🇰 Hvidovre, Denmark

Hvidovre hospital; 🇩🇰 Hvidovre, Denmark