Ulcerative ColitisCORE PracticeNCT02586259
Effectiveness of Cortiment® in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 8 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- budesonide MMX®
- How many people
- 378 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Dec 2015to 5 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from gastroenterologists (hospitals, clinics, office-based).
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Canada1 site
Digestive Health Clinic (there may be other sites in this country)
Richmond Hill
Germany1 site
Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country)
Hamburg
Ireland1 site
St. Vincent's University Hospital (there may be other sites in this country)
Dublin
Italy1 site
Investigational site (there may be other sites in this country)
Bologna
Netherlands1 site
Investigational site (there may be other sites in this country)
Amsterdam
Poland1 site
Investigational site (there may be other sites in this country)
Warsaw
Sweden1 site
Danderyds sjukhus (there may be other sites in this country)
Stockholm
United Kingdom1 site
Kings College Hospital (there may be other sites in this country)
London
About this study
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
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
- Being tested
- budesonide MMX®
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide MMX®Drug
Also called Cortiment®
| Study group | Role | What they receive |
|---|---|---|
| Cortiment® | Treatment according to routine clinical practice. Receives: Drug: budesonide MMX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit in routine practice, defined as % of patients with clinical improvement ≥ 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score
Measured: From Day 1 to end of induction treatment (recommended duration up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586259
- Sponsor's protocol ID
- 000217
- Acronym
- CORE Practice
- Status last verified
- Nov 2019
- First submitted
- 23 Oct 2015
- Last updated
- 20 Nov 2019
- Results posted
- No
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 31700630Danese 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02586259
- Acronym / sponsor ID
- CORE Practice / 000217
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cortiment® | – | Drug: budesonide MMX®Treatment according to routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from gastroenterologists (hospitals, clinics, office-based).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonide MMX®Also: Cortiment® | Drug | Cortiment® |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Results publication: PubMed 31700630Danese 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.
- Derived from this study: PubMed 27239329Danese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, Germany, Ireland, Italy, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From Day 1 to end of induction treatment (recommended duration up to 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.