Effectiveness of Cortiment® in Patients With Ulcerative Colitis

NCT02586259 | Completed

• 1 other identifier: 000217
• Study Type: observational
• Target: 378
• Locations: 8 countries
• Sites: 8

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Cortiment®

Treatment according to routine clinical practice.

Drug: budesonide MMX®

Interventions

budesonide MMX® DRUG

Also known as: Cortiment®

Cortiment®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from gastroenterologists (hospitals, clinics, office-based).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (8)

Digestive Health Clinic (there may be other sites in this country)

Richmond Hill, Canada

Location

Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country)

Hamburg, Germany

Location

St. Vincent's University Hospital (there may be other sites in this country)

Dublin, Ireland

Location

Investigational site (there may be other sites in this country)

Bologna, Italy

Location

Investigational site (there may be other sites in this country)

Amsterdam, Netherlands

Location

Investigational site (there may be other sites in this country)

Warsaw, Poland

Location

Danderyds sjukhus (there may be other sites in this country)

Stockholm, Sweden

Location

Kings College Hospital (there may be other sites in this country)

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31700630 RESULT

• 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.

  PMID: 27239329 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 26, 2015
• Study Start: December 1, 2015
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

NL (1); DE (1); PL (1); CA (1); SE (1); IT (1); GB (1); IE (1)