Clinical trial NCT06294925: A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Official title: Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colitis, Ulcerative
Keywords: patient related outcomes
real world data
S1P modulator
Symptomatic Remission
Corticosteroid free symptomatic remission
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the local approved label and independent from the decision to enroll the patient in this study.

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.


Eligibility criteria: 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.
* Severe extensive colitis evidenced by:

  1. 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.
  2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization.

     4. Prior/Concomitant Therapy:

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  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.

Primary outcomes:
measure: Proportion of patients with symptomatic remission
timeFrame: Week 12
measure: Proportion of patients with symptomatic remission
timeFrame: Week 52
Secondary outcomes:
measure: Proportion of patients with clinical response
timeFrame: Week 12
measure: Proportion of patients with clinical response.
timeFrame: Week 52
measure: Proportion of corticosteroid-free patients with symptomatic remission
timeFrame: Week 52
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: Gastroenterologie OpernstraBe
state: Hessen
city: Andernach
country: Germany
facility: Praxis Heil und Müller
city: Berlin
country: Germany
facility: MVZ für Gastroenterologie am Bayerischen Platz
city: Blaubeuren
country: Germany
facility: Alb-Donau Klinikum
city: Dachau
country: Germany
facility: MVZ Dachau
city: Frankfurt am Main
country: Germany
facility: Interdisziplinares Crohn Colitis Centrum
city: Grevenbroich
country: Germany
facility: Facharztpraxis für Gastroenterologie
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF UG.
city: Heidelberg
country: Germany
facility: Praxis für Gasteroenterologie
city: Koeln
country: Germany
facility: Evangelisches Krankenhaus Kalk
city: Lübeck
country: Germany
facility: Praxis für Gasteroenterologie Lübeck
city: Lüneburg
country: Germany
facility: Klinikum Lüneburg
city: Oldenburg
country: Germany
facility: Internistische Praxengemeinschaft Oldenburg
city: Remscheid
country: Germany
facility: Magen-Darm-Zentrum Remscheid
city: Wesseling
country: Germany
facility: CED am Rhein
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust.
state: Devon
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
state: Lanarkshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, Queens Medical Centre
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust Gastroenterology
city: Crumpsall
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust, Greater Manchester
city: Edgbaston
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust Gastroenterology
city: London
country: United Kingdom
facility: Barts Health NHS Trust, The Royal London Hospital
city: London
country: United Kingdom
facility: St. Mark's Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's Hospital - St George's Healthcare Nhs Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: