A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
- Registration Number
- NCT06294925
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
- 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.
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Presence of clinical findings suggestive of Crohn's disease.
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Severe extensive colitis evidenced by:
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Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (eg, colectomy) within 12 weeks.
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Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization.
- Prior/Concomitant Therapy:
- any previous exposure to etrasimod including participation in the etrasimod clinical program.
- any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine or tioguanine) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator.
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Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool.
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Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving etrasimod for ulcerative colitis Etrasimod -
- Primary Outcome Measures
Name Time Method Proportion of patients with symptomatic remission Week 52 Symptomatic remission was defined as stool frequency score=0/1 and rectal bleeding score=0. Stool frequency score and rectal bleeding score are components or the partial modified Mayo score: 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.
- Secondary Outcome Measures
Name Time Method Proportion of patients with clinical response Week 12 Clinical response was defined as stool frequency score/rectal bleeding score show a decrease of at least 20% from baseline or achievement of symptomatic remission.
Proportion of patients with clinical response. Week 52 Clinical response was defined as stool frequency score/rectal bleeding score show a decrease of at least 20% from baseline or achievement of symptomatic remission.
Proportion of corticosteroid-free patients with symptomatic remission Week 52 Symptomatic remission was defined as stool frequency score=0/1 and rectal bleeding score=0. Stool frequency score and rectal bleeding score are components or the partial modified Mayo score: 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.
Trial Locations
- Locations (29)
Praxis Heil und Müller
🇩🇪Andernach, Germany
Imperial College Healthcare NHS
🇬🇧London, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
Gastroenterologie OpernstraBe
🇩🇪Kassel, Hessen, Germany
MVZ für Gastroenterologie am Bayerischen Platz
🇩🇪Berlin, Germany
Alb-Donau Klinikum
🇩🇪Blaubeuren, Germany
MVZ Dachau
🇩🇪Dachau, Germany
Interdisziplinares Crohn Colitis Centrum
🇩🇪Frankfurt am Main, Germany
Facharztpraxis für Gastroenterologie
🇩🇪Grevenbroich, Germany
Studiengesellschaft BSF UG.
🇩🇪Halle (Saale), Germany
Praxis für Gasteroenterologie
🇩🇪Heidelberg, Germany
Evangelisches Krankenhaus Kalk
🇩🇪Koeln, Germany
Praxis für Gasteroenterologie Lübeck
🇩🇪Lübeck, Germany
Klinikum Lüneburg
🇩🇪Lüneburg, Germany
Internistische Praxengemeinschaft Oldenburg
🇩🇪Oldenburg, Germany
Magen-Darm-Zentrum Remscheid
🇩🇪Remscheid, Germany
CED am Rhein
🇩🇪Wesseling, Germany
Royal Devon and Exeter NHS Foundation Trust.
🇬🇧Exeter, Devon, United Kingdom
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, Lanarkshire, United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Centre
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, Oxfordshire, United Kingdom
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Cambridge University Hospitals NHS Foundation Trust Gastroenterology
🇬🇧Cambridge, United Kingdom
Northern Care Alliance NHS Foundation Trust, Greater Manchester
🇬🇧Crumpsall, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Gastroenterology
🇬🇧Edgbaston, United Kingdom
Barts Health NHS Trust, The Royal London Hospital
🇬🇧London, United Kingdom
St. Mark's Hospital
🇬🇧London, United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
St George's Hospital - St George's Healthcare Nhs Trust
🇬🇧London, United Kingdom