Clinical trial NCT02586259: Effectiveness of Cortiment® in Patients With Ulcerative Colitis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from gastroenterologists (hospitals, clinics, office-based).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical benefit in routine practice, defined as % of patients with clinical improvement ≥ 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score
timeFrame: From Day 1 to end of induction treatment (recommended duration up to 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond Hill
country: Canada
facility: Digestive Health Clinic (there may be other sites in this country)
city: Hamburg
country: Germany
facility: Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country)
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital (there may be other sites in this country)
city: Bologna
country: Italy
facility: Investigational site (there may be other sites in this country)
city: Amsterdam
country: Netherlands
facility: Investigational site (there may be other sites in this country)
city: Warszawa
country: Poland
facility: Investigational site (there may be other sites in this country)
city: Stockholm
country: Sweden
facility: Danderyds sjukhus (there may be other sites in this country)
city: London
country: United Kingdom
facility: Kings College Hospital (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
citation: 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(R) (Cortiment(R)MMX(R)) for active, mild-to-moderate ulcerative colitis. United European Gastroenterol J. 2019 Nov;7(9):1171-1182. doi: 10.1177/2050640619864848. Epub 2019 Jul 17.
citation: Danese S, Hart A, Dignass A, Louis E, D'Haens G, Dotan I, Rogler G, D'Agay L, Iannacone C, Peyrin-Biroulet L. Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study. BMJ Open Gastroenterol. 2016 May 17;3(1):e000092. doi: 10.1136/bmjgast-2016-000092. eCollection 2016.