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

April 30, 2024 updated by: Ferring Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Altenholz, Germany
        • Investigational site (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Specialist gastroenterological centres

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients newly diagnosed with Crohn's disease
This study will evaluate a new clinical scoring system in patients receiving routine treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Investigators

  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimated)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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