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O estudo clínico NCT07240168 para Colite Ulcerativa (UC) está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study 400 Baseado em biomarcador
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07240168 é um estudo observacional para Colite Ulcerativa (UC). Seu status atual é: ativo, não recrutando. O estudo começou em 7 de setembro de 2025 e pretende incluir 400 participantes. Coordenado por Evinature Ltd. e deve ser concluído em 20 de agosto de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 20 de novembro de 2025.
Resumo
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 mais
Descrição detalhada
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 mais
Título oficial
Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study
Condições médicas
Colite Ulcerativa (UC)Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- IIR-2024-200598
Número NCT
Data de início (real)
2025-09-07
Última atualização postada
2025-11-20
Data de conclusão (estimada)
2026-08-20
Inscrição (estimada)
400
Tipo de estudo
Observacional
Status
Ativo, não recrutando
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Idade mínima
8 Years
Sexos elegíveis
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 estudos clínicos ativos para explorar
Sem dados de contato.
1 Locais do estudo em 1 países
Evinature, Binyamina, Israel