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

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02193048
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Duration (Months): 88
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Other: This study will evaluate a new clinical scoring system in patients receiving routine treatment

Study Design

• Study Type: Observational
• Actual Enrollment: 216 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Evaluation of a Crohn's scoring system [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational site (there may be other sites in this country)	Altenholz		Germany

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02193048
• Other Study ID Numbers: 000150
• First Posted: Jul 17, 2014
• Last Update Posted: Jan 10, 2022
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Crohn Disease

Study Results

No Results Posted as of Jan 10, 2022