- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07597577
Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease
Comparable Efficacy of Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease: A Retrospective Cohort Study
Background & Aims: Isolated small bowel Crohn's disease (CD) is defined by involvement of the ileum, jejunum, or extensive small intestinal segments in the absence of colonic disease. This phenotype presents a therapeutic challenge, as biologic agents demonstrate reduced efficacy in this subgroup. Data on the use of upadacitinib specifically for isolated small bowel CD remain limited. This study aimed to evaluate the efficacy of upadacitinib in patients with this phenotype using the International Bowel Ultrasound Segment Activity Score (IBUS-SAS).
Methods: A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted. Based on whether the disease involved the small bowel, individuals were categorized into an isolated small bowel CD group and a non-small bowel CD group. The primary endpoint was the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS) from baseline to week 12. Secondary endpoints at week 12 included radiographic response (defined as a>25% or>2.0 mm reduction in bowel wall thickness [BWT] from baseline, or a>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade), change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI) from baseline, and changes in laboratory parameters (C-reactive protein, erythrocyte sedimentation rate). Statistical analyses included between-group comparisons, within-group comparison and logistic regression to identify predictors of radiographic response.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangzhou
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Guangdong, Guangzhou, Porcelana, 510000
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- confirmed diagnosis of Crohn's disease (CD) based on the 2023 Chinese clinical practice guidelines (Guangzhou);
- initiated upadacitinib treatment (45 mg once daily) and completed at least 12 weeks of follow-up;
- underwent intestinal ultrasound examinations both before treatment initiation and at week 12
Exclusion Criteria:
- age <18 years;
- concomitant use of other CD medications during upadacitinib treatment, including glucocorticoids, mesalazine, immunosuppressants, or biologics;
- undergoing surgical intervention during the upadacitinib treatment period
- history of other gastrointestinal diseases (e.g., ulcerative colitis, intestinal tuberculosis);
- incomplete clinical data.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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case group:isolated small bowel Crohn's disease group
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A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted.
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control group:a non-small bowel Crohn's disease group
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A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS)
Periodo de tiempo: from baseline to week 12
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The maximum value of IBUS-SAS (International Bowel Ultrasound Segment Activity Score) is 100.
The theoretical minimum is 4, but the clinically effective minimum is 0. In general, the lower the score, the milder the intestinal inflammation.
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from baseline to week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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radiographic response
Periodo de tiempo: at week 12
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defined as a>25% or>2.0 mm reduction in bowel wall thickness [BWT] from baseline, or a>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade
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at week 12
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change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI)
Periodo de tiempo: from baseline to week 12
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The Crohn's Disease Activity Index (CDAI) has a theoretical maximum of 1100 and a theoretical minimum of 0. Consistent with the definition of disease activity in this scoring system, the lower the score, the lower the disease activity and the better the clinical status.
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from baseline to week 12
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changes in laboratory parameters (C-reactive protein)
Periodo de tiempo: from baseline to week 12
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from baseline to week 12
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changes in laboratory parameters (Erythrocyte sedimentation rate)
Periodo de tiempo: from baseline to week 12
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from baseline to week 12
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.
- Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.
- Dulai PS, Singh S, Vande Casteele N, Boland BS, Rivera-Nieves J, Ernst PB, Eckmann L, Barrett KE, Chang JT, Sandborn WJ. Should We Divide Crohn's Disease Into Ileum-Dominant and Isolated Colonic Diseases? Clin Gastroenterol Hepatol. 2019 Dec;17(13):2634-2643. doi: 10.1016/j.cgh.2019.04.040. Epub 2019 Apr 19.
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
Otros números de identificación del estudio
- 2026ZSLYEC-305
Plan de datos de participantes individuales (IPD)
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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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