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

Hvidovre University Hospital

Status: Completed

Conditions: Ulcerative Colitis; Crohn's Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01468090

562_2003_2004

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Non-IBD (after reassessing diagnosis)

Trial design

192 participants in 1 patient group

Disease course

Description:

562 patients diagnosed with Crohn's disease (209), ulcerative colitis (326) or indeterminant colitis (27) in the period of 1st of January 2003 to 31st of December 2004 in Copenhagen City and County (an area covering 23% of the Danish population).