A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)
Pfizer
Summary
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.
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugEtrasimod
As provided in real world practice
Locations (22)
- Reddy GI AssociatesMesa, Arizona
- Scripps Clinic Torrey PinesLa Jolla, California
- United Medical DoctorsLos Alamitos, California
- Rocky Mountain GastroenterologyLittleton, Colorado
- Gastro FloridaLutz, Florida
- Orlando Health/Digestive Health InstituteOrlando, Florida