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

Ferring

Status: Completed

Conditions: Crohn's Disease

Treatments: Other: This study will evaluate a new clinical scoring system in patients receiving routine treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT02193048

000150

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

216 participants in 1 patient group

Patients newly diagnosed with Crohn's disease

Description:

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

Treatment:

Other: This study will evaluate a new clinical scoring system in patients receiving routine treatment