A National Multicenter Study of Etrasimod for the Treatment of Patients With Active UC

ConditionUlcerative Colitis (UC)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorTang-Du Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at baseline, of any sex.

Have a documented diagnosis of active ulcerative colitis (UC) and be judged by the treating physician as likely to benefit from etrasimod therapy. Active UC is defined as an endoscopic subscore ≥ 2, OR a stool frequency subscore (SFS) ≥ 1, OR a rectal bleeding subscore (RBS) ≥ 1. Any disease extent (Montreal classification E1, E2, or E3) is eligible. Participants must provide an endoscopy (including sigmoidoscopy) report obtained within 12 months prior to enrollment.

Have been receiving etrasimod for no more than 6 months at the time of enrollment.

Voluntarily sign a written informed consent form and have the ability to understand and complete study-related questionnaires and visit procedures.

Disqualifiers

Have any contraindication to etrasimod use as per the approved prescribing information.

Have received prior treatment with ≥ 3 biologic therapies (including infliximab, adalimumab, vedolizumab, guselkumab, risankizumab, and mirikizumab), OR ≥ 2 biologic therapies plus 1 JAK inhibitor (including upadacitinib and tofacitinib).

Have any condition that, in the investigator's judgment, may compromise data quality or threaten participant safety. The reason for exclusion must be documented.

Trial population

This study will enroll approximately 500 Chinese adults (aged ≥ 18 years) with a documented diagnosis of active ulcerative colitis (UC) who are receiving or about to start etrasimod as part of their routine clinical care. Participants will be recruited from approximately 80 hospitals across China, including tertiary referral centers and regional hospitals. Eligible participants must have active UC defined as an endoscopic subscore ≥ 2, OR a stool frequency subscore ≥ 1, OR a rectal bleeding subscore ≥ 1, with any disease extent (Montreal classification E1, E2, or E3). Participants may be either etrasimod-naïve (starting treatment at enrollment) or etrasimod-experienced (receiving etrasimod for up to 6 months at enrollment). Individuals with contraindications to etrasimod, or those who have previously received ≥ 3 biologics or ≥ 2 biologics plus 1 JAK inhibitor, will be excluded. The study population reflects the real-world UC patient population seeking care at participating gastroenter

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Etrasimod
Drug
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.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Etrasimod group including the naive and treated patients group1 intervention

Trial outcomes

Primary outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Shanghai Yicai Feiyang Public Welfare Foundation

Collaborator

Source ClinicalTrials.gov

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