Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
A Prospective, Multicenter, Non-interventional Study to Describe the Effectiveness of Etiasa® (Sustained Release Granules of Mesalazine or 5-Aminosalicylate, or 5-ASA) in Maintenance Treatment of Ulcerative Colitis (UC )
1 other identifier
observational
607
1 country
26
Brief Summary
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2013
CompletedFirst Submitted
Initial submission to the registry
September 26, 2018
CompletedFirst Posted
Study publicly available on registry
September 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2020
CompletedFebruary 2, 2021
January 1, 2021
7.6 years
September 26, 2018
January 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Median time to relapse according to the patients with different maintenance Etiasa® daily dose
Until relapse or maximum 5 years
Secondary Outcomes (8)
Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose
5 years or at study termination
Calprotectin change from baseline to each hospital visit and relapse
From baseline up to 5 years
Hemoglobin change from baseline to each hospital visit and relapse
From baseline up to 5 years
C-reactive protein (CRP) change from baseline to each hospital visit and relapse
From baseline up to 5 years
Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse
From baseline up to 5 years
- +3 more secondary outcomes
Interventions
Eligibility Criteria
Primary care clinic
You may qualify if:
- Male or Female patient ≥ 18 years old and ≤ 65 years old
- Patient has provided written informed consent to participate in the study after the purpose and nature have been clearly explained to him/her;
- Patient with documented diagnosis of mild-moderate Ulcerative Colitis (UC). The "documented diagnosis" should include a typical histology observed at least once in the course of the disease;
- Have a documented history of UC that has been successfully maintained in complete steroid-free remission for at least 1 month prior to study entry;
- The modified mayo score ≤ 2, without subscore \>1, which is supported by a rectum-sigmoidoscopy or a colonoscopy;
- Regimen of maintenance of remission contains Etiasa®
- Patient mentally and physically able to answer the questionnaire.
You may not qualify if:
- Have a history of allergy or hypersensitivity to salicylates, 5-aminosalicylates, or any component of Etiasa®;
- Pregnant and breastfeeding women, approaching childbirth female or unwilling to take birth control measures during the study;
- A topical 5-aminosalicylate agent is included in the regimen;
- Patients with infectious colitis (positive for germs, ovum or parasites causing bowel disease);
- Treated with the other study drug at enrollment, or within past 3 months of enrollment;
- Serious underlying disease other than UC which in the opinion of the investigator may interfere with the patient's ability to participate fully in the study;
- Crohn's disease;
- Pancreatitis;
- Known bleeding disorders;
- Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (26)
The Affiliated Beijing Chao-yang Hospital of Capital Medical University
Beijing, 100021, China
Peking University First Hospital
Beijing, 100034, China
China-Japan Union Hospital of Jilin University
Changchun, 130033, China
The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
Chongqing, 400042, China
The First Affiliated Hospital of Dalian Medical University
Dalian, 116000, China
The First Affiliated Hospital of Sun Yatsen University
Guangzhou, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, 510515, China
The Sixth Affiliated Hospital of Sun Yatsen University
Guangzhou, 510655, China
Hebi People Hospital
Hebi, 450018, China
Anhui Provincial Hospital
Hefei, 230001, China
Henan Province People Hospital
Henan, 450003, China
The PLA 150 Central Hospital
Luoyang, 471031, China
The First Affiliated hospital of Nan Chang University
Nanchang, 330006, China
Nanjing General Hospital of Nanjing Military Command
Nanjing, 210002, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Jiangsu Province Hospital of TCM
Nanjing, 210029, China
The Affiliated Hospital of Qingdao University
Qingdao, 266003, China
Qingdao Municipal Hospital
Qingdao, 266034, China
Suzhou Third People Hospital
Suzhou, 215000, China
The second affiliated hospital of Suzhou University
Suzhou, 215004, China
Tianjin People's Hospital
Tianjin, 300121, China
The Second Hospital Affiliated to Wenzhou Medical College
Wenzhou, 325000, China
Union Hospital Affiliated to Tongji Medical College
Wuhan, 430030, China
The People's Hospital of Wuhan University
Wuhan, 430060, China
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, 100142, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2018
First Posted
September 28, 2018
Study Start
April 24, 2013
Primary Completion
November 16, 2020
Study Completion
November 16, 2020
Last Updated
February 2, 2021
Record last verified: 2021-01