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

NCT02193048 | Completed

• 1 other identifier: 000150
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

Patients newly diagnosed with Crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Specialist gastroenterological centres

You may qualify if:

• 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

You may not qualify if:

• Pre-treatment with 5-ASA \> 10 days
• Treatment with steroids \> 10 days
• Treatment with antibiotics, immunosuppressants or biological agents \> 10 days

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

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

Altenholz, Germany

Location

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

  PMID: 38648264 RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 17, 2014
• Study Start: September 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

DE (1)