Clinical trial NCT01468090: Disease Course in an IBD Cohort in the Era of Biological Treatment
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Inflammatory bowel disease
Crohn's disease
Ulcerative colitis
Disease course
Phenotype
Biological treatment
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
name: Merck Sharp & Dohme LLC
First posted: 2011-11-09
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 562 patients diagnosed with Crohn's disease, Ulcerative colitis or indeterminant colitis in 2003-2004 i Copenhagen City and County and registered in a database.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non-IBD (after reassessing diagnosis)

Primary outcomes:
measure: Surgical rate
timeFrame: 7 years from inception (2003-04)
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Gastroenheden 360
city: Hvidovre
country: Denmark
facility: Hvidovre hospital
Study officials:
affiliation: Dep. of Gastroenterology 360, Hvidovre Hospital
name: Marianne Vester-Andersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Gastroenterology, Herlev Hospital
name: Pia Munkholm, MD, DMsc
role: STUDY_CHAIR
affiliation: Dep. of gastroenterology, Amager Hospital
name: Ida Vind, MD, PhD
role: STUDY_CHAIR
affiliation: Gastroenheden 360 Hvidovre University Hospital
name: Flemming Bendtsen, prof. DMsci
role: STUDY_DIRECTOR
References: