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NCT06398626 · ClinicalTrials.gov registry record
An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
A clinical trial of Colitis, Ulcerative, sponsored by Pfizer.
- Recruiting
- Registry status
- 300
- Enrollment target
- 20
- Study locations
NCT06398626: Recruiting study of Colitis, Ulcerative, sponsored by Pfizer.
NCT06398626 is a study of Colitis, Ulcerative that is actively recruiting participants, run by Pfizer. The registered enrollment target is 300 participants, below the 395-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06398626, a study of Colitis, Ulcerative, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Etrasimod
Study Locations (20)
Florida
- Gastro Florida - Lutz
- Orlando Health/Digestive Health Institute - Orlando
- Best Choice Medical Research Service - Pembroke Pines
- University of South Florida - Tampa
Texas
- Houston Endoscopy & Research Center - Houston
- BI Research Center - Houston
- Brooke Army Medical center - San Antonio
- GI Alliance Research - Southlake
California
- Scripps Clinic Torrey Pines - La Jolla
- United Medical Doctors - Los Alamitos
- Amicis Research Center - Valencia
Maryland
- MGG Group Co., Inc., Chevy Chase Clinical Research - Chevy Chase
- Woodholme Gastroenterology Associates PA - Glen Burnie
New York
- NYU Langone Health - New York
- Lenox Hill Hospital, Northwell Health - New York
Ohio
- University of Cincinnati College of Medicine - Cincinnati
- Gastro Intestinal Research Institute of Northern Ohio, LLC - Westlake
Arizona
- Reddy GI Associates - Mesa
Colorado
- Rocky Mountain Gastroenterology - Littleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2028-07-07 |
What NCT06398626 shows while recruiting
NCT06398626 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 395-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 1 intervention - of which Etrasimod is the first listed.
NCT06398626 names 20 study sites across 9 states, led by Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06398626 about?
NCT06398626 is a clinical study titled "An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis". 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 ...
What is the current status of trial NCT06398626?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2024-09-17. Estimated completion is 2028-07-07.
What conditions does trial NCT06398626 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT06398626?
The interventions under investigation include: Etrasimod (DRUG).
Who is sponsoring clinical trial NCT06398626?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06398626 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colitis, Ulcerative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06398626's enrollment target sits among peer trials
300 11th of 28 higher than 18 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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