Une étude pour en savoir plus sur l'efficacité de l'étrasimod chez les personnes atteintes de colite ulcéreuse (EFFECT-UC)
Efficacité de l'étrasimod sur l'activité de la maladie et les résultats rapportés par les patients dans la colite ulcéreuse - 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Aachen, Allemagne, 52064
- MVZ Gastroenterologie Aachen
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Andernach, Allemagne, 56626
- Praxis Heil und Müller
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Berlin, Allemagne, 10825
- MVZ für Gastroenterologie am Bayerischen Platz
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Cologne, Allemagne, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Allemagne, 85221
- MVZ Dachau
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Frankfurt am Main, Allemagne, 60594
- Interdisziplinares Crohn Colitis Centrum
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Grevenbroich, Allemagne, 41515
- Facharztpraxis für Gastroenterologie
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Halle, Allemagne, 06108
- Studiengesellschaft BSF UG.
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Heidelberg, Allemagne, 69115
- Praxis für Gasteroenterologie
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Lübeck, Allemagne, 23560
- Praxis für Gasteroenterologie Lübeck
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Lüneburg, Allemagne, 21339
- Klinikum Lüneburg
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Oldenburg, Allemagne, 10115
- Internistische Praxengemeinschaft Oldenburg
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Remscheid, Allemagne, 42859
- Magen-Darm-Zentrum Remscheid
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Wesseling, Allemagne, 50389
- CED am Rhein
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Breisgau
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Freiburg im Breisgau, Breisgau, Allemagne, 79102
- Gastrofreiburg
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Hesse
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Kassel, Hesse, Allemagne, 34117
- Gastroenterologie OpernstraBe
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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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Crumpsall, Royaume-Uni, M8 5RB
- Northern Care Alliance NHS Foundation Trust, Greater Manchester
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Kent, Royaume-Uni, TN2 4QJ
- Tunbridge Wells Hospital
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London, Royaume-Uni, SE59RS
- Kings College Hospital
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London, Royaume-Uni, NW1 2PG
- University College London Hospital
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London, Royaume-Uni, E1 1BB
- Barts Health NHS Trust, The Royal London Hospital
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London, Royaume-Uni, HA1 3UJ
- St. Mark's Hospital
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London, Royaume-Uni, SE1 7EH
- St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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London, Royaume-Uni, SW17 0QT
- St George's Hospital - St George's Healthcare Nhs Trust
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London, Royaume-Uni, W2 1PG
- Imperial College Healthcare NHS
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Newport, Royaume-Uni, NP20 2UB
- Royal Gwent Hospital
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Southampton, Royaume-Uni, SO16 6YD
- Southampton University Hospitals NHS Trust
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Lanarkshire
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Glasgow, Lanarkshire, Royaume-Uni, G4 0SF
- NHS Greater Glasgow and Clyde
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Nottinghamshire
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Nottingham, Nottinghamshire, Royaume-Uni, NG7 2UH
- Nottingham University Hospitals NHS Trust, Queens Medical Centre
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Oxfordshire
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Oxford, Oxfordshire, Royaume-Uni, OX3 9DU
- Oxford University Hospitals NHS Foundation Trust
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Scotland
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Edinburgh, Scotland, Royaume-Uni, EH4 2XU
- Western General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Patients recevant de l'étrasimod pour la colite ulcéreuse
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As provided in real world practice |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of patients with symptomatic remission
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of patients with clinical response
Délai: Week 12
|
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.
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C5041041
- EFFECT-UC (Autre identifiant: Alias Study Number)
Plan pour les données individuelles des participants (IPD)
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Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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