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CompletedNCT03689673Updated Feb 2, 2021

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

An observational study in Ulcerative Colitis, sponsored by Ipsen. Completed at 26 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
607
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 607 is above the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Primary care clinic

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
607 participants (actual)
Patient registry
No

Interventions

  • OtherData collection
06

What researchers measure

Primary outcomes

  1. Median time to relapse according to the patients with different maintenance Etiasa® daily dose

    Time frame: Until relapse or maximum 5 years

Secondary outcomes

  1. Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose

    Time frame: 5 years or at study termination

  2. Calprotectin change from baseline to each hospital visit and relapse

    Time frame: From baseline up to 5 years

  3. Hemoglobin change from baseline to each hospital visit and relapse

    Time frame: From baseline up to 5 years

  4. C-reactive protein (CRP) change from baseline to each hospital visit and relapse

    Time frame: From baseline up to 5 years

  5. Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse

    Time frame: From baseline up to 5 years

  6. Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse

    Time frame: From baseline up to 5 years

  7. Colorectal cancer (CRC) incidence rate

    Time frame: Until relapse or maximum 5 years

  8. 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).

    Time frame: From baseline until relapse or 5 years or early termination

07

Study locations

26 sites
  • The Affiliated Beijing Chao-yang Hospital of Capital Medical University
    Beijing, 100021, China
  • Peking University First Hospital
    Beijing, 100034, China
  • China-Japan Union Hospital of Jilin University
    Changchun, 130033, China
  • The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
    Chongqing, 400042, China
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, 116000, China
  • The First Affiliated Hospital of Sun Yatsen University
    Guangzhou, 510080, China
  • Nanfang Hospital of Southern Medical University
    Guangzhou, 510515, China
  • The Sixth Affiliated Hospital of Sun Yatsen University
    Guangzhou, 510655, China
  • Hebi People Hospital
    Hebi, 450018, China
  • Anhui Provincial Hospital
    Hefei, 230001, China
  • Henan Province People Hospital
    Henan, 450003, China
  • The PLA 150 Central Hospital
    Luoyang, 471031, China
  • The First Affiliated hospital of Nan Chang University
    Nanchang, 330006, China
  • Nanjing General Hospital of Nanjing Military Command
    Nanjing, 210002, China
  • Nanjing Drum Tower Hospital
    Nanjing, 210008, China
  • Jiangsu Province Hospital of TCM
    Nanjing, 210029, China
  • The Affiliated Hospital of Qingdao University
    Qingdao, 266003, China
  • Qingdao Municipal Hospital
    Qingdao, 266034, China
  • Suzhou Third People Hospital
    Suzhou, 215000, China
  • The second affiliated hospital of Suzhou University
    Suzhou, 215004, China
  • Tianjin People's Hospital
    Tianjin, 300121, China
  • The Second Hospital Affiliated to Wenzhou Medical College
    Wenzhou, 325000, China
  • Union Hospital Affiliated to Tongji Medical College
    Wuhan, 430030, China
  • The People's Hospital of Wuhan University
    Wuhan, 430060, China
  • The First Affiliated Hospital of the Fourth Military Medical University
    Xi'an, 100142, China
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, 450001, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03689673
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Sep 28, 2018
Start date
Apr 24, 2013
Primary completion
Nov 16, 2020
Completion
Nov 16, 2020
Last update
Feb 2, 2021

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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