NCT Number: NCT03689673
Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Peking University First Hospital, Beijing, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Median time to relapse according to the patients with different maintenance Etiasa® daily dose
Time frame: Until relapse or maximum 5 years
Secondary outcomes
-
Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose
Time frame: 5 years or at study termination
-
Calprotectin change from baseline to each hospital visit and relapse
Time frame: From baseline up to 5 years
-
Hemoglobin change from baseline to each hospital visit and relapse
Time frame: From baseline up to 5 years
-
C-reactive protein (CRP) change from baseline to each hospital visit and relapse
Time frame: From baseline up to 5 years
-
Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse
Time frame: From baseline up to 5 years
-
Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse
Time frame: From baseline up to 5 years
-
Colorectal cancer (CRC) incidence rate
Time frame: Until relapse or maximum 5 years
-
Quality of Life (QoL) changes during the treatment
Time frame: From baseline until relapse or 5 years or early termination
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).
Sponsors and collaborators
Lead sponsor
Ipsen
Industry
Registry information
Official study 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 )
Important dates
- Study start
- 2013
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Sep 28, 2018
- Registry last updated
- Feb 2, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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