Real-World Observational Study of Etrasimod for Adults with Moderate to Severe Ulcerative Colitis
Led by Pfizer · Updated on 2026-06-22
360
Participants Needed
38
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to learn about the effects of etrasimod as a treatment for adults aged 18 to 64 with moderate to severe ulcerative colitis. Patients included have not taken etrasimod before and are prescribed this treatment based on their physicians judgment as the best option. The study is observational and non-interventional, focusing on real-world use of etrasimod.
All participants will receive etrasimod according to standard medical care. The study does not change treatment schedules but includes regular health questionnaires completed online by patients using their own devices. The treatment and assessments follow usual care practices throughout the 52-week study period, followed by a 28-day safety follow-up.
Participants will visit their doctors as usual and complete health questionnaires regularly via a mobile phone, tablet, or computer. Researchers will compare each patients disease activity before and after starting etrasimod, focusing on symptomatic remission and clinical response at weeks 12 and 52. Safety is monitored during and after treatment, with the total participation lasting about one year and one month.
CONDITIONS
Brief Title
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Research Team
P
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Male and female patients aged 18 to less than 65 years at baseline
Confirmed diagnosis of moderately to severely active ulcerative colitis
Prescribed etrasimod according to the product label as part of standard care
Signed informed consent indicating understanding of the study
You will not qualify if you...
Clinical signs suggesting Crohn's disease
Severe extensive colitis likely requiring hospitalization or surgery within 12 weeks
Current evidence of acute severe ulcerative colitis, fulminant colitis, or toxic megacolon
Presence of a stoma or planned ulcerative colitis surgery requiring hospitalization
Previous exposure to etrasimod or participation in its clinical program
Use of methotrexate, thiopurines, biologics, JAK inhibitors, or other S1P receptor modulators concurrently
Lack of access or unwillingness to use a digital device for health questionnaires
Investigator site staff, Pfizer employees involved in the study, and their family members
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment and Observation
Duration - 52 weeks
Participants receive etrasimod as prescribed by their doctor and continue their usual medical visits. They also complete health questionnaires regularly online to help monitor their symptoms and disease activity.
Regular visits to treating physician as per usual care
Safety Follow-up
Duration - 28 days
Participants are monitored for safety for 28 days after completing the treatment period.
Follow-up visit(s) as needed
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Effectiveness of etrasimod on disease activity and patient-reported outcomes in ulcerative colitis-EFFECT-UC: a non-interventional, multinational, prospective cohort study protocol.
Gordon W Moran, Shellie J Radford, Alissa Walsh...