Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease | NCT02193048 | Trialant
CompletedObservationalUpdated May 2, 2024
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
ClinicalTrials.gov ID
NCT02193048
Lead Sponsor
Ferring PharmaceuticalsINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
216Actual
Last Update Posted
May 2, 2024Actual
Start Date
Sep 2014
Primary Completion Date
Dec 31, 2021Actual
Completion Date
Dec 31, 2021Actual
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.
Crohn's Disease
This study will evaluate a new clinical scoring system in patients receiving routine treatment
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Observational Model
Case-Only
Time Perspective
Prospective
No central contacts
There are no central contacts for this study.
Investigational site (there may be other sites in this country)