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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Disease Course in an IBD Cohort in the Era of Biological Treatment. Characterization of Early Predictors of Outcome and Identification of Patients in Early Need of Biological Treatment Based on an Unselected Consecutive Cohort After Seven Years Follow-up|
- Surgical rate [ Time Frame: 7 years from inception (2003-04) ] [ Designated as safety issue: No ]The risk of intestinal surgery from inception (2003-04) until 7 years of follow-up in Crohn's disease and ulcerative colitis
Biospecimen Retention: Samples With DNA
Whole blood and faeces will be retained for biobank
|Study Start Date:||October 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468090
|Hvidovre Hospital, Gastroenheden 360|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Marianne Vester-Andersen, MD||Dep. of Gastroenterology 360, Hvidovre Hospital|
|Study Chair:||Pia Munkholm, ass. prof. DMsc||Dep. of Gastroenterology, Herlev Hospital|
|Study Chair:||Ida Vind, MD, PhD||Dep. of gastroenterology, Amager Hospital|
|Study Director:||Flemming Bendtsen, prof. DMsci||Gastroenheden 360 Hvidovre University Hospital|