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

Completed

• Conditions: Distal Ulcerative Colitis
• Interventions: Drug: mesalazine

• Registration Number: NCT02368743
• Lead Sponsor: Ferring Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-02-16
• Study First Posted: 2015-02-23
• Study Start: 2015-12
• Primary Completion: 2017-03
• Study Completion: 2018-01-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mesalazine	mesalazine	Treatment according to standard clinical practice.

Primary Outcome Measures

Name	Time	Method
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score	From baseline to week 8

Trial Locations

Locations (1)

Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country); 🇫🇷 Vandoeuvre-les-Nancy, France