The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for 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 choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past. All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device. The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer. The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.
Study Type
OBSERVATIONAL
Enrollment
360
As provided in real world practice
Vancouver Coastal Health
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGProvidence Health Care (PHC)
Vancouver, British Columbia, Canada
RECRUITINGGastroenterologie OpernstraBe
Kassel, Hesse, Germany
RECRUITINGMVZ Gastroenterologie Aachen
Aachen, Germany
Proportion of patients with symptomatic remission
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
Time frame: Week 12
Proportion of patients with symptomatic remission
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
Time frame: Week 52
Proportion of patients with clinical response
Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Time frame: Week 12
Proportion of patients with clinical response.
Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Time frame: Week 52
Proportion of corticosteroid-free patients with symptomatic remission
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease. Patients have to be corticosteroid-free for at least 12 weeks prior to the visit.
Time frame: Week 52
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Praxis Heil und Müller
Andernach, Germany
RECRUITINGMVZ für Gastroenterologie am Bayerischen Platz
Berlin, Germany
RECRUITINGEvangelisches Krankenhaus Kalk
Cologne, Germany
RECRUITINGMVZ Dachau
Dachau, Germany
RECRUITINGInterdisziplinares Crohn Colitis Centrum
Frankfurt am Main, Germany
RECRUITINGFacharztpraxis für Gastroenterologie
Grevenbroich, Germany
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