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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital, Gastroenheden 360 | Hvidovre | 2650 | Denmark | |||
| Hvidovre hospital |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Whole blood and faeces will be retained for biobank
| Hvidovre |
| 2650 |
| Denmark |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |