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El ensayo clínico NCT07240168 para Colitis Ulcerosa (CU) está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study 400 Basado en biomarcadores
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07240168 es un estudio observacional para Colitis Ulcerosa (CU). Su estado actual es: activo, no reclutando. El estudio se inició el 7 de septiembre de 2025, con el objetivo de reclutar a 400 participantes. Dirigido por Evinature Ltd., se espera que finalice el 20 de agosto de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 20 de noviembre de 2025.
Resumen
This study aims to evaluate whether adding CurQD, a nutraceutical composed of Curcumin and QingDai, improves treatment outcomes in patients with active ulcerative colitis (UC) who are already receiving Vedolizumab but still have ongoing disease activity. The study will use de-identified patient records collected through Evinature's global data platform. We will examine whether the addition of CurQD helps patients sta...Mostrar más
Descripción detallada
Curcumin and QingDai, (Indigo, QD) are two herbal traditional medicine compounds which have been investigated for their use in mild-moderate and moderate-severe UC, respectively. A combination of Curcumin and QD (CurQD), which was developed at Sheba Medical Center to maximize clinical efficacy while reducing long-term high-dose QD exposure, has been used in clinical practice in Israel since 2015 and has gained wide a...Mostrar más
Título oficial
Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study
Condiciones médicas
Colitis Ulcerosa (CU)Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- IIR-2024-200598
Número del NCT
Inicio del estudio (real)
2025-09-07
Última actualización
2025-11-20
Fecha de finalización (estimada)
2026-08-20
Inscripción (prevista)
400
Tipo de estudio
Observacional
Estado general
Activo, no reclutando
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Cohort 1 (VDZ + CurQD) Patients with ulcerative colitis on Vedolizumab who initiated CurQD as adjunct therapy. | CurQD (Curcumin + QingDai combination) Patients received CurQD in addition to Vedolizumab |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD | Count of participants who remain on vedolizumab (VDZ) at Week 12 after initiating adjunct CurQD. Baseline clinical activity is defined as SCCAI ≥3 or PRO-2 ≥2 with rectal bleeding ≥1. Percentages will also be calculated relative to the number of participants with Week 12 data. | Week 12 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Participants Retaining Vedolizumab at Week 30 | Count of participants with ≥30 weeks of follow-up who remain on VDZ at Week 30 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 30 data. | Week 30 |
Number of Participants Retaining Vedolizumab at Week 54 | Count of participants with ≥54 weeks of follow-up who remain on VDZ at Week 54 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 54 data | Week 54 |
Number of Participants Achieving Clinical Remission at Week 12 | Clinical response is defined as SCCAI decrease ≥3, or PRO-2 decrease ≥2 with RB = 0 and SF ≤1, among participants with available baseline and follow-up values. Percentages will also be calculated relative to the number of participants with Week 12 clinical data. | Week 12 |
Number of Participants Achieving Clinical Response at Week 54 | Same response definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data. | Week 54 |
Number of Participants in Clinical Remission at Week 12 | Clinical remission defined as SCCAI ≤2 or PRO-2 = 0. Percentages will also be calculated relative to the number of participants with Week 12 clinical data. | Week 12 |
Number of Participants in Clinical Remission at Week 54 | Same remission definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data. | Week 54 |
Number of Participants Reporting Satisfaction with CurQD + Vedolizumab (VAS 1-10) | Number of participants providing a satisfaction score using a 1-10 Visual Analog Scale (VAS) after using CurQD + VDZ. Percentages will also be calculated relative to the number of participants who completed the VAS assessment. | Week 12 |
Number of Participants Achieving Fecal Calprotectin (FCP) Response | FCP response defined as ≥50% reduction from baseline among participants with baseline FCP ≥250 mcg/g and available follow-up FCP. Percentages will also be calculated relative to the number of participants with FCP measurements. | Up to Week 54 |
Number of Participants Achieving Fecal Calprotectin (FCP) Remission | FCP remission defined as FCP \<150 mcg/g among participants with baseline FCP ≥250 mcg/g, following STRIDE II and GEMINI-I guidance. Percentages will also be calculated relative to the number of participants with FCP measurements. | Up to Week 54 |
Number of Participants Experiencing Treatment-Emergent Adverse Events | Number and type of adverse events occurring during combined CurQD + VDZ therapy. Percentages will also be calculated relative to the number of participants exposed to both therapies. | Baseline through Week 54 |
Sensitivity Analysis: Number of Participants Retaining Vedolizumab at Week 12 with Baseline SCCAI ≥6 | Same definition as the primary endpoint but limited to participants with moderate-severe disease (baseline SCCAI ≥6). Percentages will also be calculated relative to the number of participants in this subgroup with Week 12 data. | Week 12 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto, Adulto mayor
Edad mínima
8 Years
Criterios de sexo
Todos
- Age >8 years
- Diagnosis of ulcerative colitis (self-reported)
- Completed Evinature clinical assessment between April 1, 2022, and cutoff date
- Vedolizumab treatment at baseline
- Active disease at entry (SCCAI ≥3 or PRO-2 ≥2 with RB ≥1)
- Initiated CurQD at entry
- Vedolizumab for indications other than UC
- Unclear medication status at baseline
- Not active disease when starting CurQD
Evinature Ltd.- Centro Médico Chaim Sheba
- Takeda Pharmaceutical210 estudios activos para explorar
No hay datos de contacto.
1 Centros del estudio en 1 países
Evinature, Binyamina, Israel