What is etrasimod studying for ulcerative colitis?

Etrasimod is being studied to learn about its effects on disease activity and patient-reported outcomes in people with moderate to severe ulcerative colitis. This observational study aims to understand how patients respond to etrasimod when it is prescribed as part of regular medical care.

Who may be eligible for this ulcerative colitis clinical trial?

Adults aged 18 to 64 with a confirmed diagnosis of moderate to severe ulcerative colitis may be eligible. Participants should not have used etrasimod previously and must be able to complete online health questionnaires using a digital device. Please review eligibility criteria for more details.

Is there any cost to participate in this ulcerative colitis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 18Years - 64Years

All Genders

ID06294925

Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC

Led by Pfizer · Updated on 2026-03-30

360

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of etrasimod as a treatment for adults aged 18 to 65 with moderate to severe ulcerative colitis. This real-world, observational study aims to learn how etrasimod works when prescribed according to standard medical practice, with patients chosen if their doctor believes etrasimod is the best option. Participants should not have used etrasimod before joining the study. All patients will receive etrasimod as part of their routine care, and no changes to their treatment plan will be made for the study. The study lasts 52 weeks, followed by a 28-day safety follow-up. Patients will visit their doctors as usual and are asked to complete health questionnaires online regularly using their own mobile phone, tablet, or computer. During the study, researchers will compare each patients disease activity before and after starting etrasimod. They will review measures such as the proportion of patients achieving symptomatic remission at weeks 12 and 52, clinical response rates, and corticosteroid-free remission at week 52. Patients health status will be monitored through these questionnaires and routine medical visits throughout the study period.

CONDITIONS

Brief Title

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

Who Can Participate

Age: 18Years - 64Years

All Genders

Eligibility Criteria

You may qualify if you...

Male and female patients 18 to less than 65 years of age
Confirmed diagnosis of ulcerative colitis with moderate to severe activity
Prescribed etrasimod according to product label as part of standard care
Provided signed informed consent after being informed about the study

You will not qualify if you...

Clinical signs suggesting Crohn's disease
Severe extensive colitis with likely hospitalization or surgery within 12 weeks
Evidence of acute severe ulcerative colitis, fulminant colitis, or toxic megacolon
Presence of a stoma or planned surgical intervention requiring hospitalization
Previous or current use of etrasimod, including participation in etrasimod clinical trials
Use of certain medications: methotrexate, thiopurines, biologics, JAK inhibitors, or other S1P receptor modulators
Lack of a digital device with internet access or inability/unwillingness to complete online health questionnaires
Investigator site staff, Pfizer employees involved in the study, or their family members are excluded from participation

Research Team

Pfizer CT.gov Call Center

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