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

NCT01468090 | Completed

• 1 other identifier: 562_2003_2004
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Inflammatory bowel disease; Crohn's disease; Ulcerative colitis; Disease course; Phenotype; Biological treatment

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Disease course

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Non-IBD (after reassessing diagnosis)

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Ferring Pharmaceuticals: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Hvidovre Hospital, Gastroenheden 360

Hvidovre, 2650, Denmark

Location

Hvidovre hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and faeces will be retained for biobank

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases; Disease Progression

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marianne Vester-Andersen, MD

  Dep. of Gastroenterology 360, Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

• Pia Munkholm, MD, DMsc

  Dep. of Gastroenterology, Herlev Hospital

  STUDY CHAIR

• Ida Vind, MD, PhD

  Dep. of gastroenterology, Amager Hospital

  STUDY CHAIR

• Flemming Bendtsen, prof. DMsci

  Gastroenheden 360 Hvidovre University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

DK (2)