Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT03689673
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 607
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median time to relapse according to the patients with different maintenance Etiasa® daily dose Until relapse or maximum 5 years
- Secondary Outcome Measures
Name Time Method Hemoglobin change from baseline to each hospital visit and relapse From baseline up to 5 years Calprotectin 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 Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose 5 years or at study termination Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse From baseline up to 5 years Colorectal cancer (CRC) incidence rate Until relapse or maximum 5 years Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse From baseline up to 5 years Quality of Life (QoL) changes during the treatment From baseline until relapse or 5 years or early termination Assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (score 10-70, poor to good HRQoL).
Trial Locations
- Locations (26)
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, China
Union Hospital Affiliated to Tongji Medical College
🇨🇳Wuhan, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, China
The Sixth Affiliated Hospital of Sun Yatsen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
Jiangsu Province Hospital of TCM
🇨🇳Nanjing, China
Tianjin People's Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
The Affiliated Beijing Chao-yang Hospital of Capital Medical University
🇨🇳Beijing, China
Hebi People Hospital
🇨🇳Hebi, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Henan Province People Hospital
🇨🇳Henan, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Qingdao Municipal Hospital
🇨🇳Qingdao, China
Suzhou Third People Hospital
🇨🇳Suzhou, China
The second affiliated hospital of Suzhou University
🇨🇳Suzhou, China
The Second Hospital Affiliated to Wenzhou Medical College
🇨🇳Wenzhou, China
The People's Hospital of Wuhan University
🇨🇳Wuhan, China
The First Affiliated Hospital of the Fourth Military Medical University
🇨🇳Xi'an, China
The First Affiliated Hospital of Sun Yatsen University
🇨🇳Guangzhou, China
The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
🇨🇳Chongqing, China
The PLA 150 Central Hospital
🇨🇳Luoyang, China
The First Affiliated hospital of Nan Chang University
🇨🇳Nanchang, China
Nanjing General Hospital of Nanjing Military Command
🇨🇳Nanjing, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China