A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

— EFFECT-UC  

Official title:

Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06294925
• Other study ID #: C5041041
• Secondary ID: EFFECT-UC
• Status: Not yet recruiting
• Start date: May 13, 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
• 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: Not yet 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

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	Gastroenterologie OpernstraBe	Kassel	Hessen
Germany	Praxis für Gasteroenterologie Lübeck	Lübeck
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	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