Effectiveness of Cortiment® in Patients With Ulcerative Colitis (CORE Practice)

November 18, 2019 updated by: Ferring Pharmaceuticals

A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice

The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

378

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

  • Canada
      • Richmond Hill, Canada
        • Digestive Health Clinic (there may be other sites in this country)
  • Germany
      • Hamburg, Germany
        • Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country)
  • Ireland
      • Dublin, Ireland
        • St. Vincent's University Hospital (there may be other sites in this country)
  • Italy
      • Bologna, Italy
        • Investigational site (there may be other sites in this country)
  • Netherlands
      • Amsterdam, Netherlands
        • Investigational site (there may be other sites in this country)
  • Poland
      • Warszawa, Poland
        • Investigational site (there may be other sites in this country)
  • Sweden
      • Stockholm, Sweden
        • Danderyds sjukhus (there may be other sites in this country)
  • United Kingdom
      • London, United Kingdom
        • Kings College Hospital (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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from gastroenterologists (hospitals, clinics, office-based).

Description

Inclusion Criteria:

  • Men and women aged ≥ 18 years
  • Outpatients
  • Patients who have been prescribed Cortiment® for the treatment of mild to moderate active ulcerative colitis within a 5 days' time window prior to being included in the study
  • Patients who have received adequate information regarding this non-interventional study and are able to understand and voluntarily sign the Informed Consent

Exclusion Criteria:

  • Patients with severe active / fulminant ulcerative colitis
  • Patients treated with antibiotics or corticosteroids for the current flare. Use of Antibiotics for other conditions non-related to the gastrointestinal tract, either before enrolment or during the observational period is permitted.
  • History of total / sub-total colectomy
  • Hypersensitivity to the active substance, lecithin (derived soya oil, peanut oil) or to any of the excipients
  • Patients enrolled and involved in an interventional study
  • Patients whom investigators consider inappropriate to participate in the study

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cortiment®
Treatment according to routine clinical practice.
Drug: budesonide MMX®
Other Names:
  • Cortiment®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical benefit in routine practice, defined as % of patients with clinical improvement ≥ 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score
Time Frame: From Day 1 to end of induction treatment (recommended duration up to 8 weeks)
From Day 1 to end of induction treatment (recommended duration up to 8 weeks)

Collaborators and Investigators

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

Sponsor

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

December 1, 2015

Primary Completion (Actual)

April 5, 2018

Study Completion (Actual)

April 5, 2018

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000217

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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