Tutkimus, jossa opitaan etrasimodin tehokkuudesta potilailla, joilla on haavainen paksusuolitulehdus (EFFECT-UC)
Etrasimodin tehokkuus tautiaktiivisuuteen ja potilaiden raportoimiin tuloksiin haavaisessa paksusuolentulehduksessa - 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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
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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, Saksa, 52064
- MVZ Gastroenterologie Aachen
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Andernach, Saksa, 56626
- Praxis Heil und Müller
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Berlin, Saksa, 10825
- MVZ für Gastroenterologie am Bayerischen Platz
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Cologne, Saksa, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Saksa, 85221
- MVZ Dachau
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Frankfurt am Main, Saksa, 60594
- Interdisziplinares Crohn Colitis Centrum
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Grevenbroich, Saksa, 41515
- Facharztpraxis für Gastroenterologie
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Halle, Saksa, 06108
- Studiengesellschaft BSF UG.
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Heidelberg, Saksa, 69115
- Praxis für Gasteroenterologie
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Lübeck, Saksa, 23560
- Praxis für Gasteroenterologie Lübeck
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Lüneburg, Saksa, 21339
- Klinikum Lüneburg
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Oldenburg, Saksa, 10115
- Internistische Praxengemeinschaft Oldenburg
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Remscheid, Saksa, 42859
- Magen-Darm-Zentrum Remscheid
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Wesseling, Saksa, 50389
- CED am Rhein
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Breisgau
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Freiburg im Breisgau, Breisgau, Saksa, 79102
- Gastrofreiburg
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Hesse
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Kassel, Hesse, Saksa, 34117
- Gastroenterologie OpernstraBe
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Crumpsall, Yhdistynyt kuningaskunta, M8 5RB
- Northern Care Alliance NHS Foundation Trust, Greater Manchester
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Kent, Yhdistynyt kuningaskunta, TN2 4QJ
- Tunbridge Wells Hospital
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London, Yhdistynyt kuningaskunta, SE59RS
- Kings College Hospital
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London, Yhdistynyt kuningaskunta, NW1 2PG
- University College London Hospital
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London, Yhdistynyt kuningaskunta, E1 1BB
- Barts Health NHS Trust, The Royal London Hospital
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London, Yhdistynyt kuningaskunta, HA1 3UJ
- St. Mark's Hospital
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London, Yhdistynyt kuningaskunta, SE1 7EH
- St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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London, Yhdistynyt kuningaskunta, SW17 0QT
- St George's Hospital - St George's Healthcare Nhs Trust
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London, Yhdistynyt kuningaskunta, W2 1PG
- Imperial College Healthcare NHS
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Newport, Yhdistynyt kuningaskunta, NP20 2UB
- Royal Gwent Hospital
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Southampton, Yhdistynyt kuningaskunta, SO16 6YD
- Southampton University Hospitals NHS Trust
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Lanarkshire
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Glasgow, Lanarkshire, Yhdistynyt kuningaskunta, G4 0SF
- NHS Greater Glasgow and Clyde
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Nottinghamshire
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Nottingham, Nottinghamshire, Yhdistynyt kuningaskunta, NG7 2UH
- Nottingham University Hospitals NHS Trust, Queens Medical Centre
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Oxfordshire
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Oxford, Oxfordshire, Yhdistynyt kuningaskunta, OX3 9DU
- Oxford University Hospitals NHS Foundation Trust
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Scotland
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Edinburgh, Scotland, Yhdistynyt kuningaskunta, EH4 2XU
- Western General Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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Potilaat, jotka saavat etrasimodia haavaisen paksusuolitulehduksen hoitoon
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As provided in real world practice |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of patients with symptomatic remission
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Proportion of patients with clinical response
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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. Patients have to be corticosteroid-free for at least 12 weeks prior to the visit. |
Week 52
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Pfizer CT.gov Call Center, Pfizer
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- C5041041
- EFFECT-UC (Muu tunniste: Alias Study Number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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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