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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Altenholz, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Acronym: PROGNOS

Important dates

Study start: 2014
Primary completion: 2021
Study completion: 2021
First posted: Jul 17, 2014
Registry last updated: May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed