Studie, která se dozví o účinnosti etrasimodu u lidí s ulcerózní kolitidou (EFFECT-UC)
Účinnost etrasimodu na aktivitu onemocnění a pacientem hlášené výsledky u ulcerózní kolitidy - EFEKT-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.
Přehled studie
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y 6J6
- Kelowna Gastroenterology Associates
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New Westminster, British Columbia, Kanada, V3L 3E3
- Columbia Medical Building
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Richmond, British Columbia, Kanada, V7C 5L9
- Richmond Hospital
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Vancouver Coastal Health
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Vancouver, British Columbia, Kanada, V6Z 2K5
- Providence Health Care (PHC)
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Ontario
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London, Ontario, Kanada, N6A5A5
- London Health Sciences Centre
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Ottawa, Ontario, Kanada, K1H8L6
- Ottawa Hospital
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Quebec
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Montreal, Quebec, Kanada, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Kanada, H2X 3E4
- CHUM
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Montreal, Quebec, Kanada, H4J 1C4
- Hôpital du Sacré-Cœur de Montréal
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Aachen, Německo, 52064
- MVZ Gastroenterologie Aachen
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Andernach, Německo, 56626
- Praxis Heil und Müller
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Berlin, Německo, 10825
- MVZ für Gastroenterologie am Bayerischen Platz
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Cologne, Německo, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Německo, 85221
- MVZ Dachau
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Frankfurt am Main, Německo, 60594
- Interdisziplinares Crohn Colitis Centrum
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Grevenbroich, Německo, 41515
- Facharztpraxis für Gastroenterologie
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Halle, Německo, 06108
- Studiengesellschaft BSF UG.
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Heidelberg, Německo, 69115
- Praxis für Gasteroenterologie
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Lübeck, Německo, 23560
- Praxis für Gasteroenterologie Lübeck
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Lüneburg, Německo, 21339
- Klinikum Lüneburg
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Oldenburg, Německo, 10115
- Internistische Praxengemeinschaft Oldenburg
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Remscheid, Německo, 42859
- Magen-Darm-Zentrum Remscheid
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Wesseling, Německo, 50389
- CED am Rhein
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Breisgau
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Freiburg im Breisgau, Breisgau, Německo, 79102
- Gastrofreiburg
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Hesse
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Kassel, Hesse, Německo, 34117
- Gastroenterologie OpernstraBe
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Crumpsall, Spojené království, M8 5RB
- Northern Care Alliance NHS Foundation Trust, Greater Manchester
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Kent, Spojené království, TN2 4QJ
- Tunbridge Wells Hospital
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London, Spojené království, SE59RS
- Kings College Hospital
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London, Spojené království, NW1 2PG
- University College London Hospital
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London, Spojené království, E1 1BB
- Barts Health NHS Trust, The Royal London Hospital
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London, Spojené království, HA1 3UJ
- St. Mark's Hospital
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London, Spojené království, SE1 7EH
- St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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London, Spojené království, SW17 0QT
- St George's Hospital - St George's Healthcare Nhs Trust
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London, Spojené království, W2 1PG
- Imperial College Healthcare NHS
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Newport, Spojené království, NP20 2UB
- Royal Gwent Hospital
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Southampton, Spojené království, SO16 6YD
- Southampton University Hospitals NHS Trust
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Lanarkshire
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Glasgow, Lanarkshire, Spojené království, G4 0SF
- NHS Greater Glasgow and Clyde
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Nottinghamshire
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Nottingham, Nottinghamshire, Spojené království, NG7 2UH
- Nottingham University Hospitals NHS Trust, Queens Medical Centre
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Oxfordshire
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Oxford, Oxfordshire, Spojené království, OX3 9DU
- Oxford University Hospitals NHS Foundation Trust
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Scotland
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Edinburgh, Scotland, Spojené království, EH4 2XU
- Western General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Pacienti užívající etrasimod pro ulcerózní kolitidu
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As provided in real world practice |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of patients with symptomatic remission
Časové okno: Week 12
|
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
Časové okno: Week 52
|
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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of patients with clinical response
Časové okno: 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.
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C5041041
- EFFECT-UC (Jiný identifikátor: Alias Study Number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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