Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Etrasimod
Clinical Study ID
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years and < 65 years at baseline
Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderatelyto severely active UC
Evidence of a personally signed and dated ICD indicating that the patient (or alegally acceptable representative)has been informed of all pertinent aspects of thestudy
Exclusion
Exclusion Criteria:
The presence of clinical findings suggestive of Crohn's disease
Severe extensive colitis evidenced by:
Physician judgement that the patient is likely to require hospitalization formedical or surgical intervention of any kind for UC (e.g., colectomy) within 12weeks
Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
Patients with a stoma or planned UC surgical intervention requiring hospitalization
Prior/Concomitant Therapy:
Any previous exposure to etrasimod, including participation in the etrasimodclinical program
Any co-medication with one of the following conventional therapies:methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
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
Unwillingness or inability to download the web-based tool to complete ePROs on apersonal device or not capable of using the web-based tool
Investigator site staff or Pfizer employees directly involved in the conduct of thestudy, site staff otherwise supervised by the investigator, and their respectivefamily
Study Design
Connect with a study center
Reddy GI Associates
Mesa, Arizona 85206
United StatesSite Not Available
Reddy GI Associates
Mesa 5304391, Arizona 5551752 85206
United StatesActive - Recruiting
Amicis Research Center
Valencia, California 91355
United StatesSite Not Available
Scripps Clinic Torrey Pines
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
United Medical Doctors
Los Alamitos 5368304, California 5332921 90720
United StatesSite Not Available
Amicis Research Center
Valencia 5405288, California 5332921 91355
United StatesActive - Recruiting
Rocky Mountain Gastroenterology
Littleton, Colorado 80120
United StatesSite Not Available
Rocky Mountain Gastroenterology
Littleton 5429032, Colorado 5417618 80120
United StatesActive - Recruiting
Gastro Florida
Clearwater, Florida 33756
United StatesSite Not Available
Gastro Florida
Lutz, Florida 33558
United StatesSite Not Available
Best Choice Medical Research Service
Pembroke Pines, Florida 33024
United StatesSite Not Available
Gastro Florida
Lutz 4163033, Florida 4155751 33558
United StatesTerminated
Orlando Health/Digestive Health Institute
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
Best Choice Medical Research Service
Pembroke Pines 4168139, Florida 4155751 33024
United StatesActive - Recruiting
University of South Florida
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
EBGS Clinical Research Center
Snellville, Georgia 30078
United StatesSite Not Available
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Woodholme Gastroenterology Associates PA
Glen Burnie, Maryland 21061
United StatesSite Not Available
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase 4351335, Maryland 4361885 20815
United StatesActive - Recruiting
Woodholme Gastroenterology Associates PA
Glen Burnie 4356188, Maryland 4361885 21061
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Lenox Hill Hospital, Northwell Health
New York 5128581, New York 5128638 10075
United StatesActive - Recruiting
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina 27599
United StatesSite Not Available
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesActive - Recruiting
University of Cincinnati College of Medicine
Cincinnati 4508722, Ohio 5165418 45267
United StatesActive - Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake 5176517, Ohio 5165418 44145
United StatesSite Not Available
Hightower Clinical Trial Services
Oklahoma City, Oklahoma 73102
United StatesSite Not Available
BI Research Center
Houston, Texas 77084
United StatesSite Not Available
BI Research Center
Houston 4699066, Texas 4736286 77084
United StatesActive - Recruiting
Houston Endoscopy & Research Center
Houston 4699066, Texas 4736286 77079
United StatesActive - Recruiting
Brooke Army Medical center
San Antonio 4726206, Texas 4736286 78234
United StatesSite Not Available
GI Alliance Research
Southlake 4733313, Texas 4736286 76092
United StatesActive - Recruiting
Washington Gastroenterology
Tacoma, Washington 98405
United StatesSite Not Available
Washington Gastroenterology
Tacoma 5812944, Washington 5815135 98405
United StatesActive - Recruiting
WVU Medicine J.W Ruby Memorial Hospital
Morgantown 4815352, West Virginia 4826850 26505
United StatesSite Not Available

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