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| ID | Type | Description | Link |
|---|---|---|---|
| ENDEAVOUR-UC | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with ulcerative colitis taking etrasimod |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weeks 24, 36, 52 |
| Proportion of patients with symptomatic response |
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Inclusion Criteria:
Exclusion Criteria:
The presence of clinical findings suggestive of Crohn's disease
Severe extensive colitis evidenced by:
Patients with a stoma or planned UC surgical intervention requiring hospitalization
Prior/Concomitant Therapy:
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
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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reddy GI Associates | Recruiting | Mesa | Arizona | 85206 | United States | |
| Scripps Clinic Torrey Pines |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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Symptomatic response defined as a decrease from baseline ≥ 30% in pMMS composite RBS and SFS |
| 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Weeks 12, 24, 36, 52 |
| Recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| United Medical Doctors | Recruiting | Los Alamitos | California | 90720 | United States |
| United Medical Doctors | Not yet recruiting | Los Alamitos | California | 90720 | United States |
| Rocky Mountain Gastroenterology | Recruiting | Littleton | Colorado | 80120 | United States |
| Digestive and Liver Center of Florida Kissimmee | Recruiting | Kissimmee | Florida | 34741 | United States |
| Gastro Florida | Terminated | Lutz | Florida | 33558 | United States |
| Orlando Health/Digestive Health Institute | Not yet recruiting | Orlando | Florida | 32806 | United States |
| Feinberg School of Medicine Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
| Suburban Gastroenterology Ltd | Recruiting | Naperville | Illinois | 60540 | United States |
| MGG Group Co., Inc., Chevy Chase Clinical Research | Recruiting | Chevy Chase | Maryland | 20815 | United States |
| Woodholme Gastroenterology Associates PA | Recruiting | Glen Burnie | Maryland | 21061 | United States |
| Virtua Health | Recruiting | Marlton | New Jersey | 08053 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| Lenox Hill Hospital, Northwell Health | Recruiting | New York | New York | 10075 | United States |
| University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| OnSite Clinical Solutions, LLC | Recruiting | Charlotte | North Carolina | 28211 | United States |
| University of Cincinnati College of Medicine | Recruiting | Cincinnati | Ohio | 45267 | United States |
| Gastro Intestinal Research Institute of Northern Ohio, LLC | Recruiting | Westlake | Ohio | 44145 | United States |
| Medical University of South Carolina (MUSC) | Recruiting | Charleston | South Carolina | 29425 | United States |
| Houston Endoscopy & Research Center | Recruiting | Houston | Texas | 77079 | United States |
| BI Research Center | Recruiting | Houston | Texas | 77084 | United States |
| Brooke Army Medical center | Recruiting | San Antonio | Texas | 78234 | United States |
| Brooke Army Medical center | Not yet recruiting | San Antonio | Texas | 78234 | United States |
| GI Alliance Research | Recruiting | Southlake | Texas | 76092 | United States |
| Washington Gastroenterology | Recruiting | Tacoma | Washington | 98405 | United States |
| WVU Medicine J.W Ruby Memorial Hospital | Recruiting | Morgantown | West Virginia | 26505 | United States |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000656249 | etrasimod |
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