Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease

N/ACompletedNCT02193048

Ferring Pharmaceuticals216 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

216

Conditions

Crohn's Disease

Interventions

This study will evaluate a new clinical scoring system in patients receiving routine treatmentOTHER

Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Investigational site (there may be other sites in this country)

Altenholz, Germany

Outcomes

Primary Outcomes

Evaluation of a Crohn's scoring system

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.

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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