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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-17

Study Completion Date

2028-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colitis, Ulcerative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adult patients with ulcerative colitis taking etrasimod

Etrasimod

Intervention Type DRUG

As provided in real world practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etrasimod

As provided in real world practice

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 years and \< 65 years at baseline
2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
3. Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study

Exclusion Criteria

1. The presence of clinical findings suggestive of Crohn's disease
2. Severe extensive colitis evidenced by:

1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks
2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
3. Patients with a stoma or planned UC surgical intervention requiring hospitalization
4. Prior/Concomitant Therapy:

1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program
2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
3. Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator
5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool
6. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Reach out to these primary contacts for questions about participation or study logistics.

Pfizer CT.gov Call Center

Role: CONTACT

Phone: 1-800-718-1021

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENDEAVOUR-UC

Identifier Type: OTHER

Identifier Source: secondary_id

C5041047

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Adult patients with ulcerative colitis taking etrasimod

Etrasimod

Interventions

Etrasimod

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pfizer

Responsible Party

Principal Investigators

Pfizer CT.gov Call Center

Locations

Reddy GI Associates

Scripps Clinic Torrey Pines

United Medical Doctors

Amicis Research Center

Rocky Mountain Gastroenterology

Gastro Florida

Orlando Health/Digestive Health Institute

Best Choice Medical Research Service

University of South Florida

MGG Group Co., Inc., Chevy Chase Clinical Research

Woodholme Gastroenterology Associates PA

NYU Langone Health

Lenox Hill Hospital, Northwell Health

University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

University of Cincinnati College of Medicine

Gastro Intestinal Research Institute of Northern Ohio, LLC

Houston Endoscopy & Research Center

BI Research Center

Brooke Army Medical center

GI Alliance Research

Washington Gastroenterology

WVU Medicine J.W Ruby Memorial Hospital

Countries

Central Contacts

Pfizer CT.gov Call Center

Related Links

Other Identifiers

ENDEAVOUR-UC

C5041047