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

This study has been completed.
Sponsor:
Collaborators:
Ferring Pharmaceuticals
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marianne Vester-Andersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01468090
First received: November 7, 2011
Last updated: July 6, 2014
Last verified: July 2014
  Purpose

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.


Condition
Crohn's Disease
Ulcerative Colitis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 562
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-IBD (after reassessing diagnosis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468090

Locations
Denmark
Hvidovre Hospital, Gastroenheden 360
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Ferring Pharmaceuticals
Merck Sharp & Dohme Corp.
Investigators
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
  More Information

No publications provided

Responsible Party: Marianne Vester-Andersen, Principal investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01468090     History of Changes
Other Study ID Numbers: 562_2003_2004
Study First Received: November 7, 2011
Last Updated: July 6, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Inflammatory bowel disease
Crohn's disease
Ulcerative colitis
Disease course
Phenotype
Biological treatment

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Disease Progression
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on July 08, 2014