- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02506179
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (UCanADA)
22 de enero de 2021 actualizado por: AbbVie
A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)
To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 4Z6
- University of Calgary /ID# 144032
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Edmonton, Alberta, Canadá, T6G 2X8
- Zeidler Ledcor Centre /ID# 145973
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British Columbia
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New Westminster, British Columbia, Canadá, V3L 3W5
- Columbia Gastro Mgmnt Ltd /ID# 136820
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Vancouver, British Columbia, Canadá, V6Z 2K5
- GIRI Gastrointestinal Research Institute /ID# 141107
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Victoria, British Columbia, Canadá, V8T 5G4
- Discovery Clinical Services /ID# 144102
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Victoria, British Columbia, Canadá, V8V 3M9
- Percuro Clinical Research, Ltd /ID# 136533
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New Brunswick
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Fredericton, New Brunswick, Canadá, E3B 5N5
- Dr. Everett Chalmers Reg Hosp. /ID# 136534
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St. John, New Brunswick, Canadá, E2K 1J5
- Dr Chadwick Ian Williams Professional Corporation /ID# 144802
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Ontario
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Brampton, Ontario, Canadá, L6S 0C1
- Bellini Medicine Professional /ID# 144241
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Oshawa, Ontario, Canadá, L1H 1B9
- Oshawa Clinic /ID# 144364
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Ottawa, Ontario, Canadá, K1H 8L6
- The Ottawa Hospital /ID# 139392
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Toronto, Ontario, Canadá, M53 TA9
- Kensington Screening Clinic /ID# 141106
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Toronto, Ontario, Canadá, M5G 1X5
- Mount Sinai Hosp.-Toronto /ID# 141108
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Windsor, Ontario, Canadá, N8W 1E6
- Dr O Tarabain Medicine Prof Corp /ID# 144034
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Windsor, Ontario, Canadá, N8Y 4C9
- Dr. Rahman Bacchus Med. Corp. /ID# 141780
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Quebec
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Levis, Quebec, Canadá, G6V 3Z1
- Hopital Hotel-Dieu de Levis /ID# 137099
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Montreal, Quebec, Canadá, H1T 2M4
- Hospital Maisonneuve-Rosemont /ID# 137336
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Montreal, Quebec, Canadá, H2X 3J4
- CHUM - Hopital Saint-Luc /ID# 139393
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Montreal, Quebec, Canadá, H3G 1A4
- McGill Univ HC /ID# 136821
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Montreal, Quebec, Canadá, H3P 3E5
- Clinique MEDI-CLE /ID# 153690
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Quebec City, Quebec, Canadá, G1R 2J6
- CHU de Quebec-Universite Laval /ID# 147557
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Sherbrooke, Quebec, Canadá, J1H 5N4
- CHUS - Hopital Fleurimont /ID# 137840
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7N 0W8
- Royal Univ. Hosp, Saskatoon,CA /ID# 137838
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Adult males and females with moderate to severe UC patients from Canada who meet the inclusion criteria and who do not meet any of the exclusion criteria will be eligible for enrollment into the study.
Descripción
Inclusion Criteria:
- Patient must voluntarily sign and date a patient authorization.
- Patient must be ≥ 18 years of age.
- Patient must have confirmed diagnosis of UC.
Patient must have:
- a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or
- a Mayo rectal bleeding subscore ≥ 2 and a calprotectin value greater than 250 µg/gr.
- Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
- If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice.
Exclusion Criteria:
- Patient has previously received adalimumab.
- Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
- Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
- Patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of Crohn's disease.
- Patient with other tumor necrosis factor (TNF) immune-modulated disease.
- Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
- A female patient is pregnant or breast-feeding.
- Patient is currently participating in another prospective study including controlled clinical trials and observational studies
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Open-label cohort
Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in depressive symptoms at Week 52
Periodo de tiempo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in depressive symptoms at Week 8
Periodo de tiempo: From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
|
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
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From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
|
Change from baseline in the proportion of patients with PHQ-9 >= 10
Periodo de tiempo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Disability
Periodo de tiempo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Overall quality of life
Periodo de tiempo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
|
It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Ulcerative Colitis (UC)-specific quality of life
Periodo de tiempo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Fatigue
Periodo de tiempo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
|
It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Sleep impairment,
Periodo de tiempo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Work productivity
Periodo de tiempo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in work productivity is assessed at week 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Assessing Simple Clinical Colitis Activity Index (SCCAI)
Periodo de tiempo: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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SCCAI is used to access response and remission rates.
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Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Fecal Calprotectin levels
Periodo de tiempo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in Fecal Calprotectin levels will be assessed.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Mayo endoscopic sub-score
Periodo de tiempo: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Mayo endoscopic sub-score will be assessed.
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Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Proportion of patients with Complications including hospitalization and surgery
Periodo de tiempo: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The proportion of patients with complications including hospitalization and surgery will be assessed.
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At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Proportion of patients on steroids
Periodo de tiempo: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The proportion of patients on steroids will be assessed.
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At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Physician's Global Assessment (PGA)
Periodo de tiempo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in Physician's Global Assessment (PGA) will be assessed.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
18 de agosto de 2015
Finalización primaria (Actual)
10 de febrero de 2020
Finalización del estudio (Actual)
10 de febrero de 2020
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2015
Publicado por primera vez (Estimar)
23 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P15-325
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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