Hoitomallien kuvaaminen ja päivitetyn hoitovirran luominen haavaisessa koliitin populaatiossa (EFFECT-1LAT)
Kuvailee reseptimalleja haavaisessa koliitin populaatiossa ja päivitetyn haavaisen koliitin hoidon paradigman luominen
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Exploring the long-term outcomes of uncontrolled inflammation, and how does early switching to advanced treatments affect disease outcomes and inflammation control in patients with poorly controlled ulcerative colitis.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Tadworth, Yhdistynyt kuningaskunta, KT207NS
- Pfizer
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
The Lothian IBD registry (LIBDR) was compiled through a capture-recapture methodology, describes the observed prevalence of IBD in Lothian between 2008 and 2018, and has been maintained as a prospective registry since 1 August 2018 and thus the study period is up to 1st August 2025 (2008 - 2025). The study size is expected to be a defined population of approximately 4000 UC patients, with more than 600 having commenced an advanced therapy. The study period will be from 2008 - 2025.
Kuvaus
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patient enrolled in IBD registry from 2009
- >18 years at time of diagnosis.
- Diagnosis of Ulcerative Colitis.
- Patient data entered during the study period.
- Minimum duration of data post UC diagnosis (Cohort A: 6 months, Cohort B-D 6 months)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: RETROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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Cohort A
Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy. |
As provided in real world practice
Muut nimet:
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Cohort B
Patients with uncontrolled inflammation defined as two or more episodes of raised CRP or faecal calprotectin recording 6-24 months post UC diagnosis. |
As provided in real world practice
Muut nimet:
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Cohort C
Patients with steroid dependent controlled inflammation defined as normal CRP and faecal calprotectin but the requirement of a dose of steroids between 6-24 months. |
As provided in real world practice
Muut nimet:
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Cohort D
Patients with controlled inflammation defined as the absence of steroid requirement or normal CRP or faecal calprotectin 6-24 months post UC diagnosis |
As provided in real world practice
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.
Aikaikkuna: 6-24 months from UC diagnosis.
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Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR). |
6-24 months from UC diagnosis.
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Difference in proportion of patients with inadequate control of inflammation (defined as two or more episodes of raised CRP or faecal calprotectin) treated with conventional therapeutics versus treatment escalation 24 months post UC diagnosis.
Aikaikkuna: 24 months
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Explore the differences in long term outcomes for patients with uncontrolled inflammation, treated with prolonged conventional therapeutics versus treatment escalation up to 24 months for patients with inadequate control of inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
24 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.
Aikaikkuna: Baseline demography.
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Characterise patient demography at the time of UC diagnosis and associated co-morbidities and extra-intestinal manifestations of interest in the Lothian inflammatory bowel disease registry (LIBDR). |
Baseline demography.
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Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Map treatment use from from conventional therapies to advanced therapies from time of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from Baseline in Faecal Calprotectin (Fcal).
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Generate Faecal Calprotectin (Fcal) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from Baseline in C-Reactive Protein (CRP).
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Generate C-Reactive Protein (CRP) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with colectomies from baseline.
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Assess colectomy rates of patients in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with hospitalisations from baseline.
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Assess hospitalisation rates in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.
Aikaikkuna: Study period is up to 1st August 2025 (2008 - 2025).
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Effects of conventional treatment to advanced therapies (AT's) in steroid utilisation in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from baseline in control of inflammation (CRP or faecal calprotectin) in patients that are moved from conventional treatments to advanced treatments with a UC diagnosis.
Aikaikkuna: From baseline, study period is up to 1st August 2025 (2008 - 2025).
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Describe the effects of changing from conventional treatment to advanced treatments (etrasimod and tofacitinib) in control of inflammation (CRP or faecal calprotectin) in the Lothian inflammatory bowel disease registry (LIBDR). |
From baseline, study period is up to 1st August 2025 (2008 - 2025).
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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 (Todellinen)
Opintojen valmistuminen (Todellinen)
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
Muita asiaankuuluvia MeSH-ehtoja
- Suoliston sairaudet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Paksusuolen sairaudet
- Gastroenteriitti
- Tulehdukselliset suolistosairaudet
- Koliitti
- Koliitti, haavainen
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Vasta -aineet, monoklonaalinen, humanisoitu
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Adalimumabi
- Infliksimabi
- Ustekinumabi
- guselkumabi
- risankizumabi
- vedolitsumabi
- Ozanimodi
- tofakitinibi
- etrasimodi
- GLPG0634
- golimumabi
Muut tutkimustunnusnumerot
- C5041058
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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