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 )

The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 607

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100021
    • The Affiliated Beijing Chao-yang Hospital of Capital Medical University
  • Changchun, China, 130033
    • China-Japan Union Hospital of Jilin University
  • Chongqing, China, 400042
    • The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
  • Dalian, China, 116000
    • The First Affiliated Hospital of Dalian Medical University
  • Guangzhou, China, 510515
    • Nanfang Hospital of Southern Medical University
  • Guangzhou, China, 510080
    • The First Affiliated Hospital of Sun Yatsen University
  • Guangzhou, China, 510655
    • The Sixth Affiliated Hospital of Sun Yatsen University
  • Hebi, China, 450018
    • Hebi People Hospital
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Henan, China, 450003
    • Henan Province People Hospital
  • Luoyang, China, 471031
    • The PLA 150 Central Hospital
  • Nanchang, China, 330006
    • The First Affiliated hospital of Nan Chang University
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 210002
    • Nanjing General Hospital of Nanjing Military Command
  • Nanjing, China, 210029
    • Jiangsu Province Hospital of TCM
  • Qingdao, China, 266003
    • The Affiliated Hospital of Qingdao University
  • Qingdao, China, 266034
    • Qingdao Municipal Hospital
  • Suzhou, China, 215000
    • Suzhou Third People Hospital
  • Suzhou, China, 215004
    • The Second Affiliated Hospital of Suzhou University
  • Tianjin, China, 300121
    • Tianjin People's Hospital
  • Wenzhou, China, 325000
    • The Second Hospital Affiliated to Wenzhou Medical College
  • Wuhan, China, 430030
    • Union Hospital Affiliated to Tongji Medical College
  • Wuhan, China, 430060
    • The people's Hospital of Wuhan University
  • Xi'an, China, 100142
    • The First Affiliated Hospital of the Fourth Military Medical University
  • Zhengzhou, China, 450001
    • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median time to relapse according to the patients with different maintenance Etiasa® daily dose	Until relapse or maximum 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Quality of Life (QoL) changes during the treatment	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).	From baseline until relapse or 5 years or early termination

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2013
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): November 16, 2020

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: A-38-58216-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No