Effectiveness of Cortiment® in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— CORE Practice  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586259
• Other study ID #: 000217
• Status: Completed
• Start date: December 2015
• Est. completion date: April 5, 2018

Study information

• Verified date: November 2019
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: April 5, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• budesonide MMX®

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Sweden,  United Kingdom, 

References & Publications (1)

Danese S, Hart A, Dignass A, Fiorino G, Louis E, Bonovas S, D'Haens G, Dotan I, Rogler G, Paridaens K, Peyrin-Biroulet L. A multicentre prospective cohort study assessing the effectiveness of budesonide MMX® (Cortiment®(MMX®)) for active, mild-to-moderate — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit in routine practice, defined as % of patients with clinical improvement = 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score		From Day 1 to end of induction treatment (recommended duration up to 8 weeks)