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

Ferring

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: budesonide MMX®

Study type: Observational

Funder types: Industry

Identifiers

NCT02586259

000217

Details and patient eligibility

About

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.

Enrollment: 378 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

378 participants in 1 patient group

Cortiment®

Description:

Treatment according to routine clinical practice.

Treatment:

Drug: budesonide MMX®