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| ID | Type | Description | Link |
|---|---|---|---|
| EFFECT-UC | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving etrasimod for ulcerative colitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with symptomatic remission | Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): 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 |
| Proportion of patients with symptomatic remission | Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with clinical response | Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission. | Week 12 |
| Proportion of patients with clinical response. |
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Inclusion Criteria:
Exclusion Criteria:
Presence of clinical findings suggestive of Crohn's disease.
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:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelowna Gastroenterology Associates | Recruiting | Kelowna | British Columbia | V1Y 6J6 | Canada | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41448713 | Derived | Moran GW, Radford SJ, Walsh A, Battat R, McLean M, Kudela M, Binder E, Kulchytska N, Sahin B, Helwig U, Irving PM. Effectiveness of etrasimod on disease activity and patient-reported outcomes in ulcerative colitis-EFFECT-UC: a non-interventional, multinational, prospective cohort study protocol. BMJ Open. 2025 Dec 24;15(12):e106141. doi: 10.1136/bmjopen-2025-106141. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission. |
| Week 52 |
| Proportion of corticosteroid-free patients with symptomatic remission | Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): 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 |
| Vancouver Coastal Health |
| Not yet recruiting |
| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| Vancouver Coastal Health | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Providence Health Care (PHC) | Recruiting | Vancouver | British Columbia | V6Z 2K5 | Canada |
| London Health Sciences Centre | Not yet recruiting | London | Ontario | N6A5A5 | Canada |
| Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H8L6 | Canada |
| CHUM | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
| Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
| Montreal General Hospital | Not yet recruiting | Montreal | Quebec | H3G 1A4 | Canada |
| Gastroenterologie OpernstraBe | Recruiting | Kassel | Hesse | 34117 | Germany |
| MVZ Gastroenterologie Aachen | Recruiting | Aachen | 52064 | Germany |
| Praxis Heil und Müller | Recruiting | Andernach | 56626 | Germany |
| MVZ für Gastroenterologie am Bayerischen Platz | Recruiting | Berlin | 10825 | Germany |
| Evangelisches Krankenhaus Kalk | Recruiting | Cologne | 51103 | Germany |
| MVZ Dachau | Recruiting | Dachau | 85221 | Germany |
| Interdisziplinares Crohn Colitis Centrum | Recruiting | Frankfurt am Main | 60594 | Germany |
| Facharztpraxis für Gastroenterologie | Recruiting | Grevenbroich | 41515 | Germany |
| Studiengesellschaft BSF UG. | Recruiting | Halle | 06108 | Germany |
| Praxis für Gasteroenterologie | Recruiting | Heidelberg | 69115 | Germany |
| Praxis für Gasteroenterologie Lübeck | Recruiting | Lübeck | 23560 | Germany |
| Klinikum Lüneburg | Recruiting | Lüneburg | 21339 | Germany |
| Internistische Praxengemeinschaft Oldenburg | Recruiting | Oldenburg | 10115 | Germany |
| Magen-Darm-Zentrum Remscheid | Recruiting | Remscheid | 42859 | Germany |
| CED am Rhein | Recruiting | Wesseling | 50389 | Germany |
| NHS Greater Glasgow and Clyde | Recruiting | Glasgow | Lanarkshire | G4 0SF | United Kingdom |
| Nottingham University Hospitals NHS Trust, Queens Medical Centre | Recruiting | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Western General Hospital | Recruiting | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| Northern Care Alliance NHS Foundation Trust, Greater Manchester | Recruiting | Crumpsall | M8 5RB | United Kingdom |
| Tunbridge Wells Hospital | Recruiting | Kent | TN2 4QJ | United Kingdom |
| Barts Health NHS Trust, The Royal London Hospital | Recruiting | London | E1 1BB | United Kingdom |
| St. Mark's Hospital | Recruiting | London | HA1 3UJ | United Kingdom |
| University College London Hospital | Recruiting | London | NW1 2PG | United Kingdom |
| St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
| Kings College Hospital | Recruiting | London | SE59RS | United Kingdom |
| St George's Hospital - St George's Healthcare Nhs Trust | Recruiting | London | SW17 0QT | United Kingdom |
| Imperial College Healthcare NHS | Recruiting | London | W2 1PG | United Kingdom |
| Southampton University Hospitals NHS Trust | Recruiting | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000656249 | etrasimod |
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