Clinical trial NCT02368743: QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
Official title: QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroenterologists with private and/or hospital practice

Brief 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


Eligibility criteria: 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 Informed Consent Form.

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 immunosuppressive within 1 month before study inclusion.
* Patient treated with corticosteroids within 2 weeks before study inclusion.

Primary outcomes:
measure: Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
timeFrame: From baseline to week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.