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

Ipsen

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03689673

A-38-58216-001

Details and patient eligibility

About

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

Enrollment: 607 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.