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

Ulcerative Colitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468090
• Other study ID #: 562_2003_2004
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: September 15, 2014
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-IBD (after reassessing diagnosis)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Denmark	Hvidovre hospital	Hvidovre
Denmark	Hvidovre Hospital, Gastroenheden 360	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Ferring Pharmaceuticals, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical rate	The risk of intestinal surgery from inception (2003-04) until 7 years of follow-up in Crohn's disease and ulcerative colitis	7 years from inception (2003-04)	No