Ulcerative Colitis
Conditions
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.
Interventions
DRUGbudesonide MMX®
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | From Day 1 to end of induction treatment (recommended duration up to 8 weeks) |
Countries
Canada, Germany, Ireland, Italy, Netherlands, Poland, Sweden, United Kingdom
Outcome results
None listed