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Completed

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital, Beijing, China

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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

Data Collection

Other

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

    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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