An observational study in Colitis, Ulcerative, sponsored by Pfizer. Recruiting at 28 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Pfizer · Observational
The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod.
All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer.
The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.
1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.
This study's planned enrollment of 300 is above the median of 157 across 395 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the United States etrasimod prescribing information and independent from the decision to enroll the patient in this study.
Exclusion Criteria:
Severe extensive colitis evidenced by:
Prior/Concomitant Therapy:
Drug: Etrasimod
As provided in real world practice
Proportion of patients with symptomatic remission
Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0
Time frame: Week 12
Proportion of patients with symptomatic remission
Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0
Time frame: Weeks 24, 36, 52
Proportion of patients with symptomatic response
Symptomatic response defined as a decrease from baseline ≥ 30% in pMMS composite RBS and SFS
Time frame: Weeks 12, 24, 36, 52
Proportion of patients with symptomatic response
Symptomatic response defined as a decrease from baseline ≥ 20% in pMMS composite RBS and SFS
Time frame: Weeks 12, 24, 36, 52
Proportion of patients with clinical remission
Clinical remission is defined as a pMMS ≤ 2 points, with no individual subscores \> 1 point.
Time frame: Weeks 12, 24, 36, 52
Proportion of patients with steroid-free symptomatic remission (among all patients and among patients in symptomatic remission)
Steroid-free symptomatic remission is defined as patients in symptomatic remission who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint
Time frame: Weeks 24, 36, 52
Proportion of patients with steroid-free clinical remission (among all patients and among patients in clinical remission)
Steroid-free clinical remission is defined as patients in clinical remission (using a pMMS) who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint
Time frame: Weeks 24, 36, 52
Change from baseline in fatigue
Change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score Normalization of fatigue is defined as a FACIT Fatigue score ≥ 40.1
Time frame: Weeks 12, 24, 36, 52
Change from baseline of bowel urgency
Change from baseline in bowel urgency on a 0 (no urgency) - 10 (worst possible urgency) numeric rating scale
Time frame: Weeks 12, 24, 36, 52
Proportion of patients with a clinically meaningful improvement in bowel urgency
Clinically meaningful improvement in bowel urgency is defined as ≥ 3-point decrease from baseline among patients with baseline bowel urgency score ≥ 3
Time frame: Weeks 12, 24, 36, 52
Proportion of patients in bowel urgency remission
Bowel urgency remission is defined as a bowel urgency score ≤ 1 among patients with a baseline bowel urgency score ≥ 3 and the overall population
Time frame: Weeks 12, 24, 36, 52
Proportion of patients with complete bowel urgency remission
Complete bowel urgency remission is defined as a bowel urgency Numeric Rating Scale score = 0
Time frame: Weeks 12, 24, 36, 52
Change from baseline in abdominal pain
Change from baseline in abdominal pain on a 0 (no pain) - 10 (pain as bad as can imagine) numeric rating scale
Time frame: Weeks 12, 24, 36, 52
Proportion of patients with abdominal pain remission
Abdominal pain remission is defined as an abdominal pain Numeric Rating Scale score = 0
Time frame: Weeks 12, 24, 36, 52
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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