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

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

Official Title
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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 )

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |