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

Completed

• Conditions: Crohn's Disease

• 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

Study Timeline

• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-17
• Study Start: 2014-09
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02

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

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.

Trial Locations

Locations (1)

Investigational site (there may be other sites in this country); 🇩🇪 Altenholz, Germany