Distal Ulcerative ColitisQUARTZNCT02368743
QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
An observational study of Distal Ulcerative Colitis, run by Ferring Pharmaceuticals at 1 site in France.
Trial summary
This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Ulcerative Colitis
- What is being tested?
- mesalazine
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 2 Jan 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: Gastroenterologists with private and/or hospital practice
Who may be able to join
- Patient aged 18 years or older.
- Patient suffering from mild to moderate active proctitis or distal proctosigmoiditis (MAYO score ≥ 3 and ≤ 10) at inclusion based on clinical and endoscopic findings within 6 months before study inclusion.
- Patient with evidence of endoscopic active proctitis or distal proctosigmoiditis (Montreal classification E1 or E2 defined by an involvement not exceeding 25 cm from the anal margin) within 6 months before study inclusion.
- Treatment of the current flare with Pentasa® to induce a remission initiated by the patient, the general practitioner or the gastroenterologist, during the inclusion visit or during the week before the inclusion visit.
- Patient having received oral and written information on the study, without any objections for the use of his/her personal data, and having signed a written Informed Consent Form.
Who cannot join
- Patient included in an interventional study assessing treatment for active proctitis or distal proctosigmoiditis.
- Patient with left sided, colitis or pancolitis.
- Patient with severe proctitis (MAYO score ≥ 11 at inclusion).
- Patient previously treated with biologics.
- Patient treated with immunosuppressive within 1 month before study inclusion.
- Patient treated with corticosteroids within 2 weeks before study inclusion.
Trial locations and contacts
1 site in 1 country.
France1 site
Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)
Vandœuvre-lès-Nancy
About this study
This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice
- Conditions
- Distal Ulcerative Colitis
- Being tested
- mesalazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesalazineDrug
Also called Pentasa®
| Study group | Role | What they receive |
|---|---|---|
| mesalazine | Treatment according to standard clinical practice. Receives: Drug: mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
Measured: From baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2017
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368743
- Sponsor's protocol ID
- 000179
- Acronym
- QUARTZ
- Status last verified
- Jul 2018
- First submitted
- 16 Feb 2015
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Paupard T, Gonzalez F, Caron B, Siproudhis L, Peyrin-Biroulet L. Real-world evidence of quality of life improvement in patients with distal ulcerative colitis treated by mesalazine: the Quartz study. Eur J Gastroenterol Hepatol. 2022 Dec 1;34(12):1203-1209. doi: 10.1097/MEG.0000000000002444. Epub 2022 Sep 12.
PubMed 36165055
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
- ClinicalTrials.gov ID
- NCT02368743
- Acronym / sponsor ID
- QUARTZ / 000179
- Conditions
- Distal Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 23 Feb 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.
This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesalazine | – | Drug: mesalazineTreatment according to standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastroenterologists with private and/or hospital practice
Key inclusion criteria (5 listed)
- Patient aged 18 years or older.
- Patient suffering from mild to moderate active proctitis or distal proctosigmoiditis (MAYO score ≥ 3 and ≤ 10) at inclusion based on clinical and endoscopic findings within 6 months before study inclusion.
- Patient with evidence of endoscopic active proctitis or distal proctosigmoiditis (Montreal classification E1 or E2 defined by an involvement not exceeding 25 cm from the anal margin) within 6 months before study inclusion.
- Treatment of the current flare with Pentasa® to induce a remission initiated by the patient, the general practitioner or the gastroenterologist, during the inclusion visit or during the week before the inclusion visit.
- Patient having received oral and written information on the study, without any objections for the use of his/her personal data, and having signed a written Informed Consent Form.
Key exclusion criteria (6 listed)
- Patient included in an interventional study assessing treatment for active proctitis or distal proctosigmoiditis.
- Patient with left sided, colitis or pancolitis.
- Patient with severe proctitis (MAYO score ≥ 11 at inclusion).
- Patient previously treated with biologics.
- Patient treated with immunosuppressive within 1 month before study inclusion.
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 |
|---|---|---|
| mesalazineAlso: Pentasa® | Drug | mesalazine |
Primary outcome
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
Time frame: From baseline to week 8
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 5 Jul 2018.
- Derived from this study: PubMed 36165055Paupard T, Gonzalez F, Caron B, Siproudhis L, Peyrin-Biroulet L. Real-world evidence of quality of life improvement in patients with distal ulcerative colitis treated by mesalazine: the Quartz study. Eur J Gastroenterol Hepatol. 2022 Dec 1;34(12):1203-1209. doi: 10.1097/MEG.0000000000002444. Epub 2022 Sep 12.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Ulcerative Colitis, run by Ferring Pharmaceuticals at 1 site in France.
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 5 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score (time frame: From baseline to week 8). 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 NCT02368743, which also lists 1 linked publication.
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 5 Jul 2018.