Um estudo para aprender sobre a eficácia do Etrasimod em pessoas com colite ulcerativa (EFFECT-UC)
Eficácia do Etrasimod na atividade da doença e resultados relatados pelo paciente na colite ulcerativa - 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Aachen, Alemanha, 52064
- MVZ Gastroenterologie Aachen
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Andernach, Alemanha, 56626
- Praxis Heil und Müller
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Berlin, Alemanha, 10825
- MVZ für Gastroenterologie am Bayerischen Platz
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Cologne, Alemanha, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Alemanha, 85221
- MVZ Dachau
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Frankfurt am Main, Alemanha, 60594
- Interdisziplinares Crohn Colitis Centrum
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Grevenbroich, Alemanha, 41515
- Facharztpraxis für Gastroenterologie
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Halle, Alemanha, 06108
- Studiengesellschaft BSF UG.
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Heidelberg, Alemanha, 69115
- Praxis für Gasteroenterologie
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Lübeck, Alemanha, 23560
- Praxis für Gasteroenterologie Lübeck
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Lüneburg, Alemanha, 21339
- Klinikum Lüneburg
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Oldenburg, Alemanha, 10115
- Internistische Praxengemeinschaft Oldenburg
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Remscheid, Alemanha, 42859
- Magen-Darm-Zentrum Remscheid
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Wesseling, Alemanha, 50389
- CED am Rhein
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Breisgau
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Freiburg im Breisgau, Breisgau, Alemanha, 79102
- Gastrofreiburg
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Hesse
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Kassel, Hesse, Alemanha, 34117
- Gastroenterologie OpernstraBe
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British Columbia
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Kelowna, British Columbia, Canadá, V1Y 6J6
- Kelowna Gastroenterology Associates
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New Westminster, British Columbia, Canadá, V3L 3E3
- Columbia Medical Building
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Richmond, British Columbia, Canadá, V7C 5L9
- Richmond Hospital
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver Coastal Health
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Vancouver, British Columbia, Canadá, V6Z 2K5
- Providence Health Care (PHC)
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Ontario
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London, Ontario, Canadá, N6A5A5
- London Health Sciences Centre
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Ottawa, Ontario, Canadá, K1H8L6
- Ottawa Hospital
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Quebec
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Montreal, Quebec, Canadá, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Canadá, H2X 3E4
- CHUM
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Montreal, Quebec, Canadá, H4J 1C4
- Hôpital du Sacré-Cœur de Montréal
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Crumpsall, Reino Unido, M8 5RB
- Northern Care Alliance NHS Foundation Trust, Greater Manchester
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Kent, Reino Unido, TN2 4QJ
- Tunbridge Wells Hospital
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London, Reino Unido, SE59RS
- Kings College Hospital
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London, Reino Unido, NW1 2PG
- University College London Hospital
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London, Reino Unido, E1 1BB
- Barts Health NHS Trust, The Royal London Hospital
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London, Reino Unido, HA1 3UJ
- St. Mark's Hospital
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London, Reino Unido, SE1 7EH
- St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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London, Reino Unido, SW17 0QT
- St George's Hospital - St George's Healthcare Nhs Trust
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London, Reino Unido, W2 1PG
- Imperial College Healthcare NHS
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Newport, Reino Unido, NP20 2UB
- Royal Gwent Hospital
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Southampton, Reino Unido, SO16 6YD
- Southampton University Hospitals NHS Trust
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Lanarkshire
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Glasgow, Lanarkshire, Reino Unido, G4 0SF
- NHS Greater Glasgow and Clyde
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Nottinghamshire
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Nottingham, Nottinghamshire, Reino Unido, NG7 2UH
- Nottingham University Hospitals NHS Trust, Queens Medical Centre
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Oxfordshire
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Oxford, Oxfordshire, Reino Unido, OX3 9DU
- Oxford University Hospitals NHS Foundation Trust
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Scotland
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Edinburgh, Scotland, Reino Unido, EH4 2XU
- Western General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Pacientes recebendo etrasimod para colite ulcerosa
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As provided in real world practice |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of patients with symptomatic remission
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of patients with clinical response
Prazo: 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.
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C5041041
- EFFECT-UC (Outro identificador: Alias Study Number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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