ClinicalTrials.gg
CompletedNCT02368743QUARTZUpdated Jul 5, 2018

QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)

An observational study in Distal Ulcerative Colitis, sponsored by Ferring Pharmaceuticals. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Ferring Pharmaceuticals · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
117
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Colitis, Ulcerative by Ferring Pharmaceuticals — none open to participants now, none under way, none of them phase 3. Colitis, Ulcerative · Ferring Pharmaceuticals.

Started
2015
with 4 others
Observational
9 of 19
none open now
Registered
11th of 19
by date

Among the 19 studies in Colitis, Ulcerative by Ferring Pharmaceuticals, this one is one of 5 that started in 2015, is one of 9 observational ones, and was the 11th registered.

Colitis, Ulcerative

1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.

Browse Colitis, Ulcerative studies →

Open to participants now

None of the 19 studies in Colitis, Ulcerative by Ferring Pharmaceuticals is open now. The open studies under Colitis, Ulcerative, anywhere →

Who these studies take

Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 19 studies in Colitis, Ulcerative by Ferring Pharmaceuticals as a file.
02

Study 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. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice

03

Conditions studied

  • Distal Ulcerative Colitis

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04

Who can participate

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

Study population

Gastroenterologists with private and/or hospital practice

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 Form.

Exclusion criteria

Exclusion Criteria:

  • 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 within 1 month before study inclusion.
  • Patient treated with within 2 weeks before study inclusion.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

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

Groups and cohorts

  • mesalazine

    Treatment according to standard clinical practice.

    Drug: mesalazine

Interventions

06

What researchers measure

Primary outcomes

  1. Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score

    Time frame: From baseline to week 8

07

Study locations

1 site
  • Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)
    Vandoeuvre-les-Nancy, France
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2015 to primary completion in Mar 2017, 15 months.

Of 83 industry-sponsored observational studies under Colitis, Ulcerative, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 72. This study's 15 months is below that.

Counting every sponsor, half of 271 studies reached it within 47 months; a quarter within 29 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2015
First posted
Feb 23, 2015
StartActual
Dec 2015
Primary completionActual
Mar 2017
CompletionActual
Jan 2, 2018
Last update
Jul 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02368743
Responsible party
Sponsor
First posted
Feb 23, 2015
Start date
Dec 2015
Primary completion
Mar 2017
Completion
Jan 2, 2018
Last update
Jul 5, 2018

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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