Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed
- Conditions
- Crohn's Disease
- Interventions
- Other: This study will evaluate a new clinical scoring system in patients receiving routine treatment
- Registration Number
- NCT02193048
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients newly diagnosed with Crohn's disease This study will evaluate a new clinical scoring system in patients receiving routine treatment This study will evaluate a new clinical scoring system in patients receiving routine treatment
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigational site (there may be other sites in this country)
🇩🇪Altenholz, Germany