QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
QUARTZ
1 other identifier
observational
117
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2018
CompletedJuly 5, 2018
July 1, 2018
1.2 years
February 16, 2015
July 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
From baseline to week 8
Study Arms (1)
mesalazine
Treatment according to standard clinical practice.
Interventions
Eligibility Criteria
Gastroenterologists with private and/or hospital practice
You may qualify if:
- Patient aged 18 years or older.
- 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.
You may not qualify if:
- Patient included in an interventional study assessing treatment for active proctitis or distal proctosigmoiditis.
- Patient with left sided, colitis or pancolitis.
- Patient previously treated with biologics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)
Vandœuvre-lès-Nancy, France
Related Publications (1)
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.
PMID: 36165055DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2015
First Posted
February 23, 2015
Study Start
December 1, 2015
Primary Completion
March 1, 2017
Study Completion
January 2, 2018
Last Updated
July 5, 2018
Record last verified: 2018-07