CClinicalTrials.gg
Sign In
CompletedNCT02586259CORE PracticeUpdated Nov 20, 2019

Effectiveness of Cortiment® in Patients With Ulcerative Colitis

An observational study in Ulcerative Colitis, sponsored by Ferring Pharmaceuticals. Completed at 8 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by Ferring Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
378
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 378 is above the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
378 participants (actual)
Patient registry
No

Groups and cohorts

  • Cortiment®

    Treatment according to routine clinical practice.

    Drug: budesonide MMX®

Interventions

  • Drugbudesonide MMX®

    Also known as: Cortiment®

06

What researchers measure

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

    Time frame: From Day 1 to end of induction treatment (recommended duration up to 8 weeks)

07

Study locations

8 sites
  • Digestive Health Clinic (there may be other sites in this country)
    Richmond Hill, Canada
  • Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country)
    Hamburg, Germany
  • St. Vincent's University Hospital (there may be other sites in this country)
    Dublin, Ireland
  • Investigational site (there may be other sites in this country)
    Bologna, Italy
  • Investigational site (there may be other sites in this country)
    Amsterdam, Netherlands
  • Investigational site (there may be other sites in this country)
    Warszawa, Poland
  • Danderyds sjukhus (there may be other sites in this country)
    Stockholm, Sweden
  • Kings College Hospital (there may be other sites in this country)
    London, United Kingdom
08

References and documents

Publications

  • 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. PubMed 31700630 ↗
  • 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. PubMed 27239329 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02586259
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 26, 2015
Start date
Dec 2015
Primary completion
Apr 5, 2018
Completion
Apr 5, 2018
Last update
Nov 20, 2019

Study contacts

Global Clinical Compliance
study director · Ferring Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colitis→

Other studies from this sponsor

Ferring Pharmaceuticals

Start the discussion