Crohn's Disease
Conditions
Brief summary
The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease.
Interventions
OTHERThis study will evaluate a new clinical scoring system in patients receiving routine treatment
Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients with Crohn's disease who * have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and * are as yet untreated (permitted medications are a maximum of 10 days of 5-aminosalicylates (5-ASA) or glucocorticosteroids and antibiotics for non-intestinal indications) and * have consented to the documentation of their patient data and * agree to the up to 5-year documentation of the course of disease
Exclusion criteria
* Pre-treatment with 5-ASA \> 10 days * Treatment with steroids \> 10 days * Treatment with antibiotics, immunosuppressants or biological agents \> 10 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of a Crohn's scoring system | Up to 5 years | Measured as percentage of patients with a low score at initial diagnosis having a mild course of disease during the 5 year follow-up period. |
Countries
Germany
Outcome results
None listed