An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Pfizer
Study ID
NCT06398626
Status
Recruiting
Apply to this trial

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Etrasimod — DRUG
    As provided in real world practice

Study Details

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.

Key Dates

Start date
Sep 17, 2024
Status verified
Apr 2026
Primary completion
Oct 1, 2027
Completion
Jul 7, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Adult patients with ulcerative colitis taking etrasimod

Primary Outcome Measure

Proportion of patients with symptomatic remission [ Time Frame: Week 12 ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Reddy GI AssociatesMesaArizona85206-
Scripps Clinic Torrey PinesLa JollaCalifornia92037-
United Medical DoctorsLos AlamitosCalifornia90720-
Rocky Mountain GastroenterologyLittletonColorado80120-
Gastro FloridaLutzFlorida33558-
Orlando Health/Digestive Health InstituteOrlandoFlorida32806-
Rush University Medical CenterChicagoIllinois60612-
MGG Group Co., Inc., Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
Woodholme Gastroenterology Associates PAGlen BurnieMaryland21061-
Lenox Hill Hospital, Northwell HealthNew YorkNew York10075-
NYU Langone HealthNew YorkNew York10016-
University of North Carolina at Chapel Hill, Division of Gastroenterology and HepatologyChapel HillNorth Carolina27599-
OnSite Clinical Solutions, LLCCharlotteNorth Carolina28211-
University of Cincinnati College of MedicineCincinnatiOhio45267-
Gastro Intestinal Research Institute of Northern Ohio, LLCWestlakeOhio44145-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
BI Research CenterHoustonTexas77084-
Houston Endoscopy & Research CenterHoustonTexas77079-
Brooke Army Medical centerSan AntonioTexas78234-
GI Alliance ResearchSouthlakeTexas76092-
Washington GastroenterologyTacomaWashington98405-
WVU Medicine J.W Ruby Memorial HospitalMorgantownWest Virginia26505-

Find similar trials in Mesa, AZ

By research site
Reddy GI Associates· Mesa, AZScripps Clinic Torrey Pines· La Jolla, CAUnited Medical Doctors· Los Alamitos, CARocky Mountain Gastroenterology· Littleton, COGastro Florida· Lutz, FLOrlando Health/Digestive Health Institute· Orlando, FL

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