크론병(CD)을 앓는 중국인 참가자를 대상으로 구셀쿠맙의 효능을 평가하는 연구
우스테키누마브에 대한 반응 상실 후 크론병을 앓는 중국인 참가자에서 구셀키누마브의 효능
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Guangzhou, 중국, 510655
- 모병
- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou, 중국, 510060
- 모병
- The First Affiliated Hospital Sun Yat sen University
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Hangzhou, 중국, 310018
- 모병
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hefei, 중국, 230022
- 모병
- The First Affiliated Hospital of Anhui Medical University
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Shanghai, 중국, 200031
- 모병
- Ruijin Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Has a confirmed diagnosis of Crohn's disease (CD)
- Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220
- Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks
- Initially responded to UST induction therapy and then lose response to UST
- During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
Exclusion Criteria:
- Received UST dose optimization or multiple intravenous therapy in maintenance phase
- Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
- Is currently enrolled in an interventional clinical study
- Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
- Have a current or be suspected to have an abscess
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Guselkumab Treatment
Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy. |
Guselkumab will be administered intravenously or by subcutaneous injection.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Achieving Clinical Remission At Week 48
기간: At Week 48
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Clinical remission is defined as less than (<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
At Week 48
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48
기간: At Weeks 12, 24 and 48
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Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
At Weeks 12, 24 and 48
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Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24
기간: At Weeks 12 and 24
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Clinical remission is defined as < 150-point reduction in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
At Weeks 12 and 24
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Percentage of Participants Achieving Endoscopic Response
기간: At Weeks 24 and 48
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Endoscopic response is defined as >= 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease. |
At Weeks 24 and 48
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Percentage of Participants Achieving Endoscopic Remission
기간: At Weeks 24 and 48
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Endoscopic remission is defined as SES-CD less than or equal to (<=) 2 in any individual component. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease. |
At Weeks 24 and 48
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Baseline Characteristics of Participants With Endoscopic Remission: Age
기간: Baseline
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Baseline characteristics of participants (age) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Sex
기간: Baseline
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Baseline characteristics of participants (sex) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Height
기간: Baseline
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Baseline characteristics of participants (height) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Weight
기간: Baseline
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Baseline characteristics of participants (weight) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications
기간: Baseline
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Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities
기간: Baseline
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Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures
기간: Baseline
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Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported. |
Baseline
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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Xi'an Janssen Pharmaceutical Clinical Trial, Xi'an Janssen Pharmaceutical
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- CNTO1959CRD4007
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
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