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

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ClinicalTrials.gov Identifier: NCT01468090
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
Ferring Pharmaceuticals
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marianne Vester-Andersen, Hvidovre University Hospital

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.


Condition or disease
Crohn's Disease Ulcerative Colitis

Study Type : Observational
Actual Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : October 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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).



Primary Outcome Measures :
  1. Surgical rate [ Time Frame: 7 years from inception (2003-04) ]
    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


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468090


Locations
Denmark
Hvidovre Hospital, Gastroenheden 360
Hvidovre, Denmark, 2650
Hvidovre hospital
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, MD, 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

Responsible Party: Marianne Vester-Andersen, Principal investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01468090     History of Changes
Other Study ID Numbers: 562_2003_2004
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

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

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