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NCT02193048 Clinical Trial

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

Crohn's Disease Clinical Trial

— PROGNOS  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02193048
Other study ID # 000150
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date December 31, 2021

Study information
Verified date April 2024
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 216
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• This study will evaluate a new clinical scoring system in patients receiving routine treatment
Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.

Locations
Country Name City State
Germany Investigational site (there may be other sites in this country) Altenholz

Sponsors (1)
Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kruis W, Bokemeyer B, Jessen P, Hoesl M, Mross M, Morgenstern J, Reimers B, Muller-Grage N, Leifeld L. Prospective Evaluation of the Prediction Score for a Mild Course of Crohn's Disease (PreMiCC) in Newly Diagnosed Patients With Crohn's Disease: The PROG — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Up to 5 years
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