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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06294925
Other study ID # C5041041
Secondary ID EFFECT-UC
Status Recruiting
Phase
First received
Last updated
Start date May 8, 2024
Est. completion date May 13, 2027

Study information

Verified date May 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date May 13, 2027
Est. primary completion date April 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Presence of clinical findings suggestive of Crohn's disease. - Planned surgical intervention - Prior/Concomitant Therapy: 1. any previous exposure to etrasimod including participation in the etrasimod clinical program. 2. 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. - 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. - 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


Related Conditions & MeSH terms


Intervention

Drug:
Etrasimod
As provided in real world practice

Locations

Country Name City State
Germany Praxis Heil und Müller Andernach
Germany MVZ für Gastroenterologie am Bayerischen Platz Berlin
Germany MVZ Dachau Dachau
Germany Interdisziplinares Crohn Colitis Centrum Frankfurt am Main
Germany Studiengesellschaft BSF UG. Halle (Saale)
Germany Praxis für Gasteroenterologie Heidelberg
Germany Gastroenterologie OpernstraBe Kassel Hessen
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
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 Western General Hospital Edinburgh Scotland
United Kingdom Royal Devon and Exeter NHS Foundation Trust. Exeter Devon
United Kingdom NHS Greater Glasgow and Clyde Glasgow Lanarkshire
United Kingdom St George's Hospital - St George's Healthcare Nhs Trust London
United Kingdom St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust London
United Kingdom St. Mark's Hospital London
United Kingdom Nottingham University Hospitals NHS Trust, Queens Medical Centre Nottingham Nottinghamshire
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with symptomatic remission 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. Week 12
Primary Proportion of patients with symptomatic remission 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. Week 52
Secondary Proportion of patients with clinical response 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. Week 12
Secondary Proportion of patients with clinical response. 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. Week 52
Secondary Proportion of corticosteroid-free patients with symptomatic remission 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. Week 52
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