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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03689673
Other study ID # A-38-58216-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 24, 2013
Est. completion date November 16, 2020

Study information

Verified date January 2021
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 607
Est. completion date November 16, 2020
Est. primary completion date November 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection


Locations

Country Name City State
China Peking University First Hospital Beijing
China The Affiliated Beijing Chao-yang Hospital of Capital Medical University Beijing
China China-Japan Union Hospital of Jilin University Changchun
China The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA Chongqing
China The First Affiliated Hospital of Dalian Medical University Dalian
China Nanfang Hospital of Southern Medical University Guangzhou
China The First Affiliated Hospital of Sun Yatsen University Guangzhou
China The Sixth Affiliated Hospital of Sun Yatsen University Guangzhou
China Hebi People Hospital Hebi
China Anhui Provincial Hospital Hefei
China Henan Province People Hospital Henan
China The PLA 150 Central Hospital Luoyang
China The First Affiliated hospital of Nan Chang University Nanchang
China Jiangsu Province Hospital of TCM Nanjing
China Nanjing Drum Tower Hospital Nanjing
China Nanjing General Hospital of Nanjing Military Command Nanjing
China Qingdao Municipal Hospital Qingdao
China The Affiliated Hospital of Qingdao University Qingdao
China Suzhou Third People Hospital Suzhou
China The second affiliated hospital of Suzhou University Suzhou
China Tianjin People's Hospital Tianjin
China The Second Hospital Affiliated to Wenzhou Medical College Wenzhou
China The People's Hospital of Wuhan University Wuhan
China Union Hospital Affiliated to Tongji Medical College Wuhan
China The First Affiliated Hospital of the Fourth Military Medical University Xi'an
China The First Affiliated Hospital of Zhengzhou University Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median time to relapse according to the patients with different maintenance Etiasa® daily dose Until relapse or maximum 5 years
Secondary Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose 5 years or at study termination
Secondary Calprotectin change from baseline to each hospital visit and relapse From baseline up to 5 years
Secondary Hemoglobin change from baseline to each hospital visit and relapse From baseline up to 5 years
Secondary C-reactive protein (CRP) change from baseline to each hospital visit and relapse From baseline up to 5 years
Secondary Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse From baseline up to 5 years
Secondary Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse From baseline up to 5 years
Secondary Colorectal cancer (CRC) incidence rate Until relapse or maximum 5 years
Secondary 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
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