Ulcerative Colitis
Conditions
Brief summary
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
Interventions
OTHERData collection
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time to relapse according to the patients with different maintenance Etiasa® daily dose | Until relapse or maximum 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calprotectin change from baseline to each hospital visit and relapse | From baseline up to 5 years | — |
| Hemoglobin change from baseline to each hospital visit and relapse | From baseline up to 5 years | — |
| C-reactive protein (CRP) change from baseline to each hospital visit and relapse | From baseline up to 5 years | — |
| Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose | 5 years or at study termination | — |
| Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse | From baseline up to 5 years | — |
| Colorectal cancer (CRC) incidence rate | Until relapse or maximum 5 years | — |
| Quality of Life (QoL) changes during the treatment | 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). |
| Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse | From baseline up to 5 years | — |
Countries
China
Outcome results
None listed