Effectiveness of Cortiment® in Patients With Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: budesonide MMX®

• Registration Number: NCT02586259
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Study Start: 2015-12
• Primary Completion: 2018-04-05
• Study Completion: 2018-04-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cortiment®	budesonide MMX®	Treatment according to routine clinical practice.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (6)

Danderyds sjukhus (there may be other sites in this country); 🇸🇪 Stockholm, Sweden

St. Vincent's University Hospital (there may be other sites in this country); 🇮🇪 Dublin, Ireland

Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country); 🇩🇪 Hamburg, Germany

Digestive Health Clinic (there may be other sites in this country); 🇨🇦 Richmond Hill, Canada

Investigational site (there may be other sites in this country); 🇵🇱 Warszawa, Poland

Kings College Hospital (there may be other sites in this country); 🇬🇧 London, United Kingdom