Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD
研究概览
简要总结
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 stay on Vedolizumab longer, improves symptoms and biomarkers, and increases satisfaction with treatment.
详细描述
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 acceptance by UC patients and IBD experts [1,2]. In two multi-center retrospective studies, CurQD was found effective in inducing clinical and biomarker remission in both adult and pediatric patients, including in patients who were refractory to biologic and/or small molecules [3,4], and recent evidence from a pediatric cohort in the U.S also documented intestinal sonographic response to CurQD [5]. In a placebo-controlled randomized trial from Israel and Greece, CurQD was found superior to placebo in inducing and maintaining clinical and endoscopic remission without any safety signals [6,7]. Moreover, the study also showed the active compounds in CurQD exerts agonistic up-regulation of Aryl-hydrocarbon Receptor pathway in the rectal mucosa [6], supporting its unique non-immunosuppressive mode-of-action. Subsequently, CurQD has been increasingly used by IBD experts in academic centers in the USA and elsewhere as Add-on therapy in patients with partial or non-response to biologics and/or small molecules medications. Recently, CurQD became the first and only nutraceutical to date to pass the CCFA Ingestible committee examination of supporting clinical and scientific data to allow its endorsement by the CCFA. Collectively, these data provide the rationale for exploring large scale population-based impact of combining CurQD with a biologic.
The present retrospective cohort study will interrogate the Evinature GDPR HIPAA compliant database to identify patients who started CurQD while being treated with VDZ. The study will investigate the clinical benefit of adding CurQD in combination with VDZ, in patients partially responding or not-responding to VDZ.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Vedolizumab for indications other than UC
- •Unclear medication status at baseline
- •Not active disease when starting CurQD
结局指标
主要结局
Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD
时间窗: Week 12
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.
次要结局
- Number of Participants Retaining Vedolizumab at Week 30(Week 30)
- Number of Participants Retaining Vedolizumab at Week 54(Week 54)
- Number of Participants Achieving Clinical Remission at Week 12(Week 12)
- Number of Participants Achieving Clinical Response at Week 54(Week 54)
- Number of Participants in Clinical Remission at Week 12(Week 12)
- Number of Participants in Clinical Remission at Week 54(Week 54)
- Number of Participants Reporting Satisfaction with CurQD + Vedolizumab (VAS 1-10)(Week 12)
- Number of Participants Achieving Fecal Calprotectin (FCP) Response(Up to Week 54)
- Number of Participants Achieving Fecal Calprotectin (FCP) Remission(Up to Week 54)
- Number of Participants Experiencing Treatment-Emergent Adverse Events(Baseline through Week 54)
- Sensitivity Analysis: Number of Participants Retaining Vedolizumab at Week 12 with Baseline SCCAI ≥6(Week 12)