Een onderzoek om meer te weten te komen over de effectiviteit van Etrasimod bij mensen met colitis ulcerosa (EFFECT-UC)
Effectiviteit van Etrasimod op de ziekteactiviteit en door de patiënt gerapporteerde resultaten bij colitis ulcerosa - EFFECT-UC
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 6J6
- Kelowna Gastroenterology Associates
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New Westminster, British Columbia, Canada, V3L 3E3
- Columbia Medical Building
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Richmond, British Columbia, Canada, V7C 5L9
- Richmond Hospital
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver Coastal Health
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Vancouver, British Columbia, Canada, V6Z 2K5
- Providence Health Care (PHC)
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Ontario
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London, Ontario, Canada, N6A5A5
- London Health Sciences Centre
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Ottawa, Ontario, Canada, K1H8L6
- Ottawa Hospital
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Canada, H2X 3E4
- CHUM
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Montreal, Quebec, Canada, H4J 1C4
- Hôpital du Sacré-Cœur de Montréal
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Aachen, Duitsland, 52064
- MVZ Gastroenterologie Aachen
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Andernach, Duitsland, 56626
- Praxis Heil und Müller
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Berlin, Duitsland, 10825
- MVZ für Gastroenterologie am Bayerischen Platz
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Cologne, Duitsland, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Duitsland, 85221
- MVZ Dachau
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Frankfurt am Main, Duitsland, 60594
- Interdisziplinares Crohn Colitis Centrum
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Grevenbroich, Duitsland, 41515
- Facharztpraxis für Gastroenterologie
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Halle, Duitsland, 06108
- Studiengesellschaft BSF UG.
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Heidelberg, Duitsland, 69115
- Praxis für Gasteroenterologie
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Lübeck, Duitsland, 23560
- Praxis für Gasteroenterologie Lübeck
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Lüneburg, Duitsland, 21339
- Klinikum Lüneburg
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Oldenburg, Duitsland, 10115
- Internistische Praxengemeinschaft Oldenburg
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Remscheid, Duitsland, 42859
- Magen-Darm-Zentrum Remscheid
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Wesseling, Duitsland, 50389
- CED am Rhein
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Breisgau
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Freiburg im Breisgau, Breisgau, Duitsland, 79102
- Gastrofreiburg
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Hesse
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Kassel, Hesse, Duitsland, 34117
- Gastroenterologie OpernstraBe
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Crumpsall, Verenigd Koninkrijk, M8 5RB
- Northern Care Alliance NHS Foundation Trust, Greater Manchester
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Kent, Verenigd Koninkrijk, TN2 4QJ
- Tunbridge Wells Hospital
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London, Verenigd Koninkrijk, SE59RS
- Kings College Hospital
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London, Verenigd Koninkrijk, NW1 2PG
- University College London Hospital
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London, Verenigd Koninkrijk, E1 1BB
- Barts Health NHS Trust, The Royal London Hospital
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London, Verenigd Koninkrijk, HA1 3UJ
- St. Mark's Hospital
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London, Verenigd Koninkrijk, SE1 7EH
- St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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London, Verenigd Koninkrijk, SW17 0QT
- St George's Hospital - St George's Healthcare Nhs Trust
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London, Verenigd Koninkrijk, W2 1PG
- Imperial College Healthcare NHS
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Newport, Verenigd Koninkrijk, NP20 2UB
- Royal Gwent Hospital
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Southampton, Verenigd Koninkrijk, SO16 6YD
- Southampton University Hospitals NHS Trust
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Lanarkshire
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Glasgow, Lanarkshire, Verenigd Koninkrijk, G4 0SF
- NHS Greater Glasgow and Clyde
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Nottinghamshire
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Nottingham, Nottinghamshire, Verenigd Koninkrijk, NG7 2UH
- Nottingham University Hospitals NHS Trust, Queens Medical Centre
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Oxfordshire
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Oxford, Oxfordshire, Verenigd Koninkrijk, OX3 9DU
- Oxford University Hospitals NHS Foundation Trust
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Scotland
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Edinburgh, Scotland, Verenigd Koninkrijk, EH4 2XU
- Western General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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:
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Presence of clinical findings suggestive of Crohn's disease.
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Severe extensive colitis evidenced by:
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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.
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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:
- 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.
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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.
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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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Patiënten die etrasimod krijgen voor colitis ulcerosa
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As provided in real world practice |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of patients with symptomatic remission
Tijdsspanne: Week 12
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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
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Proportion of patients with symptomatic remission
Tijdsspanne: Week 52
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of patients with clinical response
Tijdsspanne: Week 12
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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 12
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Proportion of patients with clinical response.
Tijdsspanne: Week 52
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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
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Proportion of corticosteroid-free patients with symptomatic remission
Tijdsspanne: Week 52
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- C5041041
- EFFECT-UC (Andere identificatie: Alias Study Number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
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