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임상시험 NCT07240168은(는) 궤양성 대장염 (UC)에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study 400 바이오마커 기반
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07240168은(는) 궤양성 대장염 (UC)에 대해 알아보는 관찰연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2025년 9월 7일에 시작되어 400명의 참여자를 모집하고 있습니다. Evinature Ltd.이(가) 진행하며, 2026년 8월 20일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 20일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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...더 보기
공식 제목
Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study
질환명
궤양성 대장염 (UC)출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- IIR-2024-200598
NCT 번호
실제 연구 시작일
2025-09-07
최신 업데이트 게시
2025-11-20
예상 연구 완료일
2026-08-20
계획된 등록 인원
400
연구종류
관찰연구
상태
진행중, 모집종료
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
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 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
8 Years
참여 가능한 성별
전체
- 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.- 셰바 메디컬 센터
- 다케다 제약210개의 진행 중인 임상시험 탐색 가능
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Evinature, Binyamina, Israel