Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes symptoms such as bloody diarrhea, abdominal pain, and frequent bowel movements. It can significantly affect patients' quality of life. Etrasimod is an oral medication taken once daily that has been shown in clinical trials to be effective for treating active UC. However, clinical trial results may not fully reflect how the drug works in real-world clinical practice, where patients have more diverse backgrounds and medical conditions. This is a prospective, multicenter, observational registry study conducted at approximately 80 hospitals across China. The study will enroll about 500 Chinese adults with active UC who are receiving or about to start treatment with etrasimod. Participants will be followed for at least 52 weeks. The study does not assign any treatment-all participants receive etrasimod as part of their routine clinical care, and treatment decisions are made by their doctors. The main goal of this study is to describe the characteristics of Chinese adults with active UC who are treated with etrasimod in real-world settings, including their age, sex, disease duration, disease activity, and prior treatments. The study will also track how UC symptoms change over time, how often disease flares occur, and how treatment is adjusted during follow-up. Additional goals include describing medication use patterns, changes in physician-assessed and patient-reported outcomes, treatment-related economic burden, and safety information including adverse events. Data will be collected at baseline and at Weeks 2, 12, 24, and 52 through routine clinic visits, medical records, and patient questionnaires. The study will help provide a more complete understanding of how etrasimod performs in everyday clinical practice in China.
Ulcerative colitis (UC) is a chronic inflammatory condition of the large intestine that causes symptoms such as bloody stools, frequent diarrhea, abdominal cramps, and an urgent need to move the bowels. These symptoms often come and go over time, and the unpredictable nature of the disease can severely disrupt daily activities, work, and emotional well-being. While several treatments are available, many patients do not achieve lasting remission or may experience side effects. Etrasimod is a once-daily oral medication that works by modulating immune cell activity in the gut to reduce inflammation. Although clinical trials have shown that etrasimod is effective and generally safe for treating active UC, data from routine clinical practice-where patients have a wider range of health conditions, treatment histories, and lifestyle factors-are still limited, especially in the Chinese population. To address this gap, this study is designed as a prospective, multicenter, observational registry. It is not a clinical trial, meaning that no study medication is assigned or provided by the research team. All enrolled participants are already prescribed etrasimod by their own doctors as part of their standard medical care. The study will be conducted at approximately 80 hospitals across China and aims to enroll about 500 adults aged 18 years or older who have active UC and have been receiving etrasimod for no more than 6 months at the time of enrollment. Participants will be followed for at least 52 weeks (12 months). Those who have previously used three or more biological therapies, or two biological therapies plus one JAK inhibitor, are not eligible to join. The study includes two participant groups. The first group consists of patients who are starting etrasimod for the first time at enrollment. The second group includes patients who have already been taking etrasimod for up to 6 months before joining, for whom past medical data will be collected retrospectively. All participants will attend routine clinic visits at baseline (enrollment), Week 2, Week 12, Week 24, and Week 52. These visits align with normal clinical care, and the study does not require any additional tests beyond what doctors would typically order for managing UC. At each study visit, data will be collected from medical records and patient-completed questionnaires. Information collected includes participants' age, sex, disease duration, disease extent and severity, previous treatments, and any other health conditions. The study will track changes in UC symptoms-such as stool frequency and rectal bleeding-as well as disease flare-ups, adjustments in treatment, and the development of new health issues. Participants will be asked to complete validated questionnaires, including the Inflammatory Bowel Disease Questionnaire (IBDQ), which measures quality of life, and the 8-item Morisky Medication Adherence Scale (MMAS-8), which assesses how well participants follow their prescribed treatment plan. The study will also collect information on healthcare costs, including medication expenses, hospitalization fees, and indirect costs such as transportation and lost work time. In terms of clinical outcomes, the study will describe disease activity using the partial Mayo score, which evaluates stool frequency and bleeding. For those who undergo routine endoscopy as part of their care, the study will record endoscopic findings and, when available, tissue biopsy results to assess mucosal healing. Blood and stool tests, including C-reactive protein (CRP) and fecal calprotectin (FCP), will also be collected if performed in routine practice. Safety is an important focus; the study will systematically document any adverse events or serious adverse events that occur during follow-up. A planned interim analysis will be performed when approximately 40% of the target enrollment (about 200 participants) is reached, to assess data quality and recruitment progress. No efficacy comparisons or hypothesis testing will be conducted in this interim review. All final analyses will be descriptive in nature, summarizing participant characteristics, treatment patterns, clinical outcomes, patient-reported outcomes, and safety data over the 52-week period. The findings from this registry are expected to provide valuable real-world evidence on the use of etrasimod in Chinese adults with active UC. This information will help clinicians better understand how the medication performs in everyday practice, support informed treatment decisions, and ultimately improve the management and quality of life for patients living with UC in China.
Study Type
OBSERVATIONAL
Enrollment
500
Intervention Type: Drug Intervention Name: Etrasimod Description: Etrasimod 2 mg tablet, taken orally once daily (swallowed whole, not crushed or chewed). Participants receive etrasimod as part of routine clinical care. The recommended treatment duration in this registry is at least 52 weeks, but dosing adjustments and discontinuation are at the discretion of the treating physician. Etrasimod is a selective sphingosine-1-phosphate (S1P) receptor modulator (targeting S1PR1, S1PR4, and S1PR5) that reduces lymphocyte trafficking to the gut, thereby decreasing intestinal inflammation.
Tangdu Hospital
Xi’an, Shanxi, China
Baseline Demographic and Clinical Characteristics of Chinese Adults with Active UC Receiving Etrasimod
At enrollment (baseline), the following descriptive data are collected from medical records, electronic health systems, and patient interviews: Demographic information: age, sex, ethnicity, region of residence, marital status, occupation, education level, income level, health insurance type, smoking status, and alcohol use. UC disease characteristics: age at UC diagnosis, time from symptom onset to confirmed diagnosis, disease duration, disease extent (Montreal classification: E1/E2/E3), disease severity (modified Truelove and Witts classification: mild/moderate/severe), baseline disease activity (modified Mayo score, partial Mayo score including stool frequency subscore and rectal bleeding subscore), presence of extraintestinal manifestations (e.g., joint, skin, eye), and prior UC treatments including medications and surgeries. History of previous biologic or JAK inhibitor use. All data are collected at a single time point (enrollment) and are derived from existing clinical recor
Time frame: Enrollment (baseline)
Disease Control Status in Chinese Adults with Active UC Receiving Etrasimod Over 52 Weeks
Over the 52-week follow-up period, disease control is assessed descriptively through the following parameters collected from routine clinic visits, electronic medical records, and patient-completed questionnaires at baseline and at Weeks 2, 12, 24, and 52: Changes in UC-related clinical manifestations: improvements or worsening of stool frequency, rectal bleeding, and other UC symptoms, assessed using the partial Mayo score (stool frequency subscore and rectal bleeding subscore), recorded daily for 7 days before each visit. Disease flare (relapse) events: timing of each relapse, relapse frequency, disease activity at the time of relapse (assessed by partial Mayo score), and post-relapse disease management strategies (including medications added, changed, or discontinued). Concomitant therapy adjustments: for all UC-related concomitant medications, the generic drug name, treatment regimen, reason for treatment change or discontinuation, and any new treatments initiated are documente
Time frame: From enrollment (baseline) through the 52-week follow-up visit.
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