Skip to main content
Clinical Trials/NCT02193048
NCT02193048
Completed
Not Applicable

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

Ferring Pharmaceuticals1 site in 1 country216 target enrollmentSeptember 2014
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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Loading locations...

Similar Trials