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

Ferring

Status: Completed

Conditions: Distal Ulcerative Colitis

Treatments: Drug: mesalazine

Study type: Observational

Funder types: Industry

Identifiers

NCT02368743

000179

Details and patient eligibility

About

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

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

117 participants in 1 patient group

mesalazine

Description:

Treatment according to standard clinical practice.

Treatment:

Drug: mesalazine