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

January 29, 2021 updated by: Ipsen

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 )

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
607

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100021
        • The Affiliated Beijing Chao-yang Hospital of Capital Medical University
      • Changchun, China, 130033
        • China-Japan Union Hospital of Jilin University
      • Chongqing, China, 400042
        • The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
      • Dalian, China, 116000
        • The First Affiliated Hospital of Dalian Medical University
      • Guangzhou, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, China, 510080
        • The First Affiliated Hospital of Sun Yatsen University
      • Guangzhou, China, 510655
        • The Sixth Affiliated Hospital of Sun Yatsen University
      • Hebi, China, 450018
        • Hebi People Hospital
      • Hefei, China, 230001
        • Anhui Provincial Hospital
      • Henan, China, 450003
        • Henan Province People Hospital
      • Luoyang, China, 471031
        • The PLA 150 Central Hospital
      • Nanchang, China, 330006
        • The First Affiliated hospital of Nan Chang University
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital
      • Nanjing, China, 210002
        • Nanjing General Hospital of Nanjing Military Command
      • Nanjing, China, 210029
        • Jiangsu province hospital of TCM
      • Qingdao, China, 266003
        • The Affiliated Hospital of Qingdao University
      • Qingdao, China, 266034
        • Qingdao Municipal Hospital
      • Suzhou, China, 215000
        • Suzhou Third People Hospital
      • Suzhou, China, 215004
        • The Second Affiliated Hospital of Suzhou University
      • Tianjin, China, 300121
        • Tianjin People's Hospital
      • Wenzhou, China, 325000
        • The Second Hospital Affiliated to Wenzhou Medical College
      • Wuhan, China, 430030
        • Union Hospital Affiliated to Tongji Medical College
      • Wuhan, China, 430060
        • The people's Hospital of Wuhan University
      • Xi'an, China, 100142
        • The First Affiliated Hospital of the Fourth Military Medical University
      • Zhengzhou, China, 450001
        • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Median time to relapse according to the patients with different maintenance Etiasa® daily dose
Time Frame: Until relapse or maximum 5 years
Until relapse or maximum 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose
Time Frame: 5 years or at study termination
5 years or at study termination
Calprotectin change from baseline to each hospital visit and relapse
Time Frame: From baseline up to 5 years
From baseline up to 5 years
Hemoglobin change from baseline to each hospital visit and relapse
Time Frame: From baseline up to 5 years
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
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
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
From baseline up to 5 years
Colorectal cancer (CRC) incidence rate
Time Frame: Until relapse or maximum 5 years
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).
From baseline until relapse or 5 years or early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-38-58216-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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