NCT06294925Active, not recruiting
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
EFFECTIVENESS OF ETRASIMOD ON DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN ULCERATIVE COLITIS - EFFECT-UC
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 360 (estimated)
- First submitted
- 28 Feb 2024
- Start date
- 8 May 2024
- Primary completion date
- 13 May 2027
- Lead sponsor
- Pfizer
- Diseases
- Ulcerative colitis
- NCT number
- NCT06294925
What you commit to
- Study type: Observational
- Planned participants: 360
- From 8 May 2024 to the primary completion date, 13 May 2027
- 41 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe extensive colitis evidenced by:
- 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.
- 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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- 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.
Other illness
- Presence of clinical findings suggestive of Crohn's disease.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kelowna Gastroenterology Associates Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Montreal General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hôpital du Sacré-Cœur de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Columbia Medical Building Coordinator of this site? Confirm its status | New Westminster | Canada | Unknown status |
| Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Richmond Hospital Coordinator of this site? Confirm its status | Richmond | Canada | Unknown status |
| Vancouver Coastal Health Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Providence Health Care (PHC) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| MVZ Gastroenterologie Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Praxis Heil und Müller Coordinator of this site? Confirm its status | Andernach | Germany | Unknown status |
| MVZ für Gastroenterologie am Bayerischen Platz Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Evangelisches Krankenhaus Kalk Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| MVZ Dachau Coordinator of this site? Confirm its status | Dachau | Germany | Unknown status |
| Interdisziplinares Crohn Colitis Centrum Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Gastrofreiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Facharztpraxis für Gastroenterologie Coordinator of this site? Confirm its status | Grevenbroich | Germany | Unknown status |
| Studiengesellschaft BSF UG. Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Praxis für Gasteroenterologie Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Gastroenterologie OpernstraBe Coordinator of this site? Confirm its status | Kassel | Germany | Unknown status |
| Praxis für Gasteroenterologie Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Klinikum Luneburg Coordinator of this site? Confirm its status | Lüneburg | Germany | Unknown status |
| Internistische Praxengemeinschaft Oldenburg Coordinator of this site? Confirm its status | Oldenburg | Germany | Unknown status |
| Magen-Darm-Zentrum Remscheid Coordinator of this site? Confirm its status | Remscheid | Germany | Unknown status |
| CED am Rhein Coordinator of this site? Confirm its status | Wesseling | Germany | Unknown status |
| Northern Care Alliance NHS Foundation Trust, Greater Manchester Coordinator of this site? Confirm its status | Crumpsall | United Kingdom | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| NHS Greater Glasgow and Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Tunbridge Wells Hospital Coordinator of this site? Confirm its status | Kent | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St Mark's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust , The Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St George's Hospital - St George's Healthcare Nhs Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Gwent Hospital Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust, Queens Medical Centre Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Southampton University Hospitals NHS Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.