Describir patrones de tratamiento y crear un flujo de tratamiento actualizado en una población de colitis ulcerosa (EFFECT-1LAT)
Describir patrones de prescripción en una población de colitis ulcerosa y generar un paradigma actualizado de tratamiento de colitis ulcerosa
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Tadworth, Reino Unido, KT207NS
- Pfizer
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cohort A
Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy. |
As provided in real world practice
Otros nombres:
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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
Otros nombres:
|
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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
Otros nombres:
|
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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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.
Periodo de tiempo: 6-24 months from UC diagnosis.
|
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.
|
|
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.
Periodo de tiempo: 24 months
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.
Periodo de tiempo: Baseline demography.
|
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.
|
|
Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
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).
|
|
Change from Baseline in Faecal Calprotectin (Fcal).
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
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).
|
|
Change from Baseline in C-Reactive Protein (CRP).
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
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).
|
|
Proportion of patients with colectomies from baseline.
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
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.
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
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).
|
|
Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
|
|
Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
|
|
Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.
Periodo de tiempo: Study period is up to 1st August 2025 (2008 - 2025).
|
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.
Periodo de tiempo: From baseline, study period is up to 1st August 2025 (2008 - 2025).
|
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).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades intestinales
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Gastroenteritis
- Enfermedades inflamatorias del intestino
- Colitis
- Colitis Ulcerativa
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Adalimumab
- Infliximab
- Ustekinumab
- guselkumab
- risankizumab
- vedolizumab
- ozanimod
- tofacitinib
- etrasimod
- GLPG0634
- golimumab
Otros números de identificación del estudio
- C5041058
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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