NCT02193048
Completed
Not Applicable
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
ConditionsCrohn's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Evaluation of a Crohn's scoring system
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluation of a Crohn's scoring system
Time Frame: 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.
Study Sites (1)
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