Phase
Condition
Crohn's Disease
Inflammatory Bowel 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 has beeninformed of all pertinent aspects of the study
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 StatesActive - Recruiting
Amicis Research Center
Valencia, California 91355
United StatesActive - Recruiting
Rocky Mountain Gastroenterology
Littleton, Colorado 80120
United StatesSite Not Available
Gastro Florida
Clearwater, Florida 33756
United StatesActive - Recruiting
Gastro Florida
Lutz, Florida 33558
United StatesActive - Recruiting
Best Choice Medical Research Service
Pembroke Pines, Florida 33024
United StatesActive - Recruiting
EBGS Clinical Research Center
Snellville, Georgia 30078
United StatesActive - Recruiting
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesActive - Recruiting
Woodholme Gastroenterology Associates PA
Glen Burnie, Maryland 21061
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Hightower Clinical Trial Services
Oklahoma City, Oklahoma 73102
United StatesActive - Recruiting
BI Research Center
Houston, Texas 77084
United StatesSite Not Available
Washington Gastroenterology
Tacoma, Washington 98405
United StatesActive - Recruiting
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