Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)

Ulcerative Colitis Clinical Trial

Official title:

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 )

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689673
• Other study ID #: A-38-58216-001
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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