Clinical trial NCT03689673: Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
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 )
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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


Eligibility criteria: 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.

Primary outcomes:
measure: Median time to relapse according to the patients with different maintenance Etiasa® daily dose
timeFrame: Until relapse or maximum 5 years
Secondary outcomes:
measure: Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose
timeFrame: 5 years or at study termination
measure: Calprotectin change from baseline to each hospital visit and relapse
timeFrame: From baseline up to 5 years
measure: Hemoglobin change from baseline to each hospital visit and relapse
timeFrame: From baseline up to 5 years
measure: C-reactive protein (CRP) change from baseline to each hospital visit and relapse
timeFrame: From baseline up to 5 years
measure: Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse
timeFrame: From baseline up to 5 years
measure: Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse
timeFrame: From baseline up to 5 years
measure: Colorectal cancer (CRC) incidence rate
timeFrame: Until relapse or maximum 5 years
measure: Quality of Life (QoL) changes during the treatment
timeFrame: From baseline until relapse or 5 years or early termination
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Affiliated Beijing Chao-yang Hospital of Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
city: Chongqing
country: China
facility: The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yatsen University
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yatsen University
city: Hebi
country: China
facility: Hebi People Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Henan
country: China
facility: Henan Province People Hospital
city: Luoyang
country: China
facility: The PLA 150 Central Hospital
city: Nanchang
country: China
facility: The First Affiliated hospital of Nan Chang University
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital of TCM
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Suzhou
country: China
facility: Suzhou Third People Hospital
city: Suzhou
country: China
facility: The second affiliated hospital of Suzhou University
city: Tianjin
country: China
facility: Tianjin People's Hospital
city: Wenzhou
country: China
facility: The Second Hospital Affiliated to Wenzhou Medical College
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College
city: Wuhan
country: China
facility: The People's Hospital of Wuhan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of the Fourth Military Medical University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: