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

NCT ID: NCT02193048

Last Updated: 2024-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients newly diagnosed with Crohn's disease

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

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Altenholz, , Germany

Site Status

Countries

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Germany

References

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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 PROGNOS Study. Inflamm Bowel Dis. 2025 Mar 3;31(3):677-685. doi: 10.1093/ibd/izae086.

Reference Type RESULT
PMID: 38648264 (View on PubMed)

Other Identifiers

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000150

Identifier Type: -

Identifier Source: org_study_id

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