Ulcerative ColitisNCT03689673
Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
An observational study of Ulcerative Colitis, run by Ipsen at 26 sites in China.
Trial summary
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Data collection
- How many people
- 607 participants
- Where
- 26 sitesChina
- Study dates
- 24 Apr 2013to 16 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- Crohn's disease;
- Pancreatitis;
- Known bleeding disorders;
- Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
The Affiliated Beijing Chao-yang Hospital of Capital Medical University
Beijing, 100021
Peking University First Hospital
Beijing, 100034
China-Japan Union Hospital of Jilin University
Changchun, 130033
The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
Chongqing, 400042
The First Affiliated Hospital of Dalian Medical University
Dalian, 116000
The First Affiliated Hospital of Sun Yatsen University
Guangzhou, 510080
Nanfang Hospital of Southern Medical University
Guangzhou, 510515
The Sixth Affiliated Hospital of Sun Yatsen University
Guangzhou, 510655
Hebi People Hospital
Hebi, 450018
Anhui Provincial Hospital
Hefei, 230001
Henan Province People Hospital
Henan, 450003
The PLA 150 Central Hospital
Luoyang, 471031
The First Affiliated hospital of Nan Chang University
Nanchang, 330006
Nanjing General Hospital of Nanjing Military Command
Nanjing, 210002
Nanjing Drum Tower Hospital
Nanjing, 210008
Jiangsu Province Hospital of TCM
Nanjing, 210029
The Affiliated Hospital of Qingdao University
Qingdao, 266003
Qingdao Municipal Hospital
Qingdao, 266034
Suzhou Third People Hospital
Suzhou, 215000
The second affiliated hospital of Suzhou University
Suzhou, 215004
Tianjin People's Hospital
Tianjin, 300121
The Second Hospital Affiliated to Wenzhou Medical College
Wenzhou, 325000
Union Hospital Affiliated to Tongji Medical College
Wuhan, 430030
The People's Hospital of Wuhan University
Wuhan, 430060
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, 100142
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450001
About this study
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 )
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
- Conditions
- Ulcerative Colitis
- Being tested
- Data collection
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to relapse according to the patients with different maintenance Etiasa® daily dose
Measured: Until relapse or maximum 5 years
Secondary outcomes (8)
Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose
Measured: 5 years or at study termination
Calprotectin change from baseline to each hospital visit and relapse
Measured: From baseline up to 5 years
Hemoglobin change from baseline to each hospital visit and relapse
Measured: From baseline up to 5 years
C-reactive protein (CRP) change from baseline to each hospital visit and relapse
Measured: From baseline up to 5 years
Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse
Measured: From baseline up to 5 years
Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse
Measured: From baseline up to 5 years
Colorectal cancer (CRC) incidence rate
Measured: 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).
Measured: From baseline until relapse or 5 years or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start24 Apr 2013
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689673
- Sponsor's protocol ID
- A-38-58216-001
- Status last verified
- Jan 2021
- First submitted
- 26 Sep 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 )
- ClinicalTrials.gov ID
- NCT03689673
- Acronym / sponsor ID
- A-38-58216-001
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2013 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection | Other | – |
Primary outcome
Median time to relapse according to the patients with different maintenance Etiasa® daily dose
Time frame: Until relapse or maximum 5 years
8 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Ipsen at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time to relapse according to the patients with different maintenance Etiasa® daily dose (time frame: Until relapse or maximum 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.