Um Estudo para Avaliar a Eficácia de Guselkumab em Participantes Chineses com Doença de Crohn (DC)
Eficácia do Guselkumab em Participantes Chineses com Doença de Crohn após Perda de Resposta ao Ustekinumab
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Study Contact
- Número de telefone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Locais de estudo
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Guangzhou, China, 510655
- Recrutamento
- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou, China, 510060
- Recrutamento
- The First Affiliated Hospital Sun Yat sen University
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Hangzhou, China, 310018
- Recrutamento
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hefei, China, 230022
- Recrutamento
- The First Affiliated Hospital of Anhui Medical University
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Shanghai, China, 200031
- Recrutamento
- Ruijin Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Achieving Clinical Remission At Week 48
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Xi'an Janssen Pharmaceutical Clinical Trial, Xi'an Janssen Pharmaceutical
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CNTO1959CRD4007
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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
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