Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Male and female patients ≥18 and \<65 years of age at baseline
• Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study.
• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Locations
Other Locations
Canada
Providence Health Care (PHC)
RECRUITING
Vancouver
Vancouver Coastal Health
NOT_YET_RECRUITING
Vancouver
Germany
MVZ Gastroenterologie Aachen
RECRUITING
Aachen
Praxis Heil und Müller
RECRUITING
Andernach
MVZ für Gastroenterologie am Bayerischen Platz
RECRUITING
Berlin
Evangelisches Krankenhaus Kalk
RECRUITING
Cologne
MVZ Dachau
RECRUITING
Dachau
Interdisziplinares Crohn Colitis Centrum
RECRUITING
Frankfurt Am Main
Facharztpraxis für Gastroenterologie
RECRUITING
Grevenbroich
Studiengesellschaft BSF UG.
RECRUITING
Halle
Praxis für Gasteroenterologie
RECRUITING
Heidelberg
Gastroenterologie OpernstraBe
RECRUITING
Kassel
Praxis für Gasteroenterologie Lübeck
RECRUITING
Lübeck
Klinikum Lüneburg
RECRUITING
Lüneburg
Internistische Praxengemeinschaft Oldenburg
RECRUITING
Oldenburg
Magen-Darm-Zentrum Remscheid
RECRUITING
Remscheid
CED am Rhein
RECRUITING
Wesseling
United Kingdom
Northern Care Alliance NHS Foundation Trust, Greater Manchester
RECRUITING
Crumpsall
Western General Hospital
RECRUITING
Edinburgh
NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
Tunbridge Wells Hospital
RECRUITING
Kent
Barts Health NHS Trust, The Royal London Hospital
RECRUITING
London
Imperial College Healthcare NHS
RECRUITING
London
Kings College Hospital
RECRUITING
London
St George's Hospital - St George's Healthcare Nhs Trust
RECRUITING
London
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
RECRUITING
London
St. Mark's Hospital
RECRUITING
London
University College London Hospital
RECRUITING
London
Nottingham University Hospitals NHS Trust, Queens Medical Centre
RECRUITING
Nottingham
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Southampton University Hospitals NHS Trust
RECRUITING
Southampton
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2024-05-08
Estimated Completion Date:2027-05-13
Participants
Target number of participants:360
Treatments
Patients receiving etrasimod for ulcerative colitis