A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis (GALILEO)
Guselkumab: A Real Life Non-Interventional, Persistence and Effectiveness Study in Patients With Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
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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Santiago de Compostela, Espanha, 15706
- Hosp. Clinico Univ. de Santiago
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.
Descrição
Inclusion criteria:
- Participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not
- Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (>)4 for CD and Partial Mayo Score (pMS)>2 for UC
- Participant [and/or their legally-acceptable representative where applicable] must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
Exclusion criteria:
- Contraindicated to guselkumab per the label
- It is currently enrolled in an interventional clinical study
- Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included
- History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
- Is unable to provide the ICF
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: OTHER
Coortes e Intervenções
Grupo / Coorte |
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Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Participants with confirmed diagnosis of moderate-to-severe UC or CD receiving guselkumab according to clinical practice will be enrolled. Only data available within clinical routine as standard of care will be documented for this study. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Persistence of Treatment with Guselkumab
Prazo: Up to 96 weeks
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Persistence of treatment with guselkumab will be measured through time to guselkumab discontinuation defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion. |
Up to 96 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Prazo: Up to 96 weeks
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Participants reporting effectiveness with treatment of guselkumab will be measured through the HBI for CD. Clinical response for CD is defined as the HBI score less than or equal to (<=) 4 or a decrease in HBI by greater than or equal to (>=) 3 from baseline. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain (AP), number of liquid stools per day, abdominal mass and complications. |
Up to 96 weeks
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Number of Participants Achieving Clinical Response for CD as Measured by Patient Reported Outcome (PRO-2)
Prazo: Up to 96 weeks
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Number of participants with clinical response to guselkumab will be assessed using PRO-2, including stool frequency and abdominal pain in CD participants through the patient's electronic (e)-diary. |
Up to 96 weeks
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Number of Participants Achieving Clinical Response for Ulcerative colitis (UC) as Measured by Partial Mayo Score (PMS)
Prazo: Up to 96 weeks
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Participants reporting effectiveness with treatment of guselkumab will be measured through the PMS for UC. Clinical response for UC is defined as the PMS score < 4 or >= 30 percent (%) reduction from baseline. PMS comprises 3 categories: rectal bleeding, stool frequency, and physician assessment. |
Up to 96 weeks
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Number of Participants Achieving Clinical Response for UC as Measured by PRO-2
Prazo: Up to 96 weeks
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Number of participants achieving clinical response to guselkumab will be assessed using PRO-2, including stool frequency and rectal bleeding in UC participants through the patient's e-diary. |
Up to 96 weeks
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Characteristics of Participants Receiving Guselkumab Treatment: Age
Prazo: At Week 0
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Age of participants receiving guselkumab treatment will be reported. |
At Week 0
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Characteristics of Participants Receiving Guselkumab Treatment: Sex
Prazo: At Week 0
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Sex of participants receiving guselkumab treatment will be reported. |
At Week 0
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Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use
Prazo: At Week 0
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Participants with previous IBD medication use will be reported. |
At Week 0
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Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Prazo: At Week 0
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Smoking status and history of participants receiving guselkumab treatment will be reported. |
At Week 0
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Characteristics of Participants Receiving Guselkumab Treatment: Height
Prazo: At Week 0
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Height of participants receiving guselkumab treatment will be reported. |
At Week 0
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Characteristics of Participants Receiving Guselkumab Treatment: Weight
Prazo: At Weeks 0, 4, 12, 48 and 96
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Weight of participants receiving guselkumab treatment will be reported. |
At Weeks 0, 4, 12, 48 and 96
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Characteristics of Participants Receiving Guselkumab Treatment: Disease Status
Prazo: Up to 96 weeks
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Disease status of participants receiving guselkumab treatment will be reported. |
Up to 96 weeks
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Characteristics of Participants Receiving Guselkumab Treatment: Severity at Index
Prazo: Up To 96 weeks
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Disease severity of participants will be reported. |
Up To 96 weeks
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Characteristics of Participants Receiving Guselkumab Treatment: Age At Diagnosis
Prazo: At Week 0
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Age at diagnosis of participants receiving guselkumab treatment will be reported. |
At Week 0
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Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Prazo: At Week 0
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Participants disease duration at study initiation will be reported. |
At Week 0
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Number of Participants with Comorbid Diagnoses
Prazo: Up to 96 weeks
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Participants with comorbid diagnoses will be reported. |
Up to 96 weeks
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Number of Participants with History of UC/CD Previous IBD Related Therapy Use and Surgeries
Prazo: At Week 0
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Participants with history of UC/CD and previous IBD-related therapy use and surgeries will be reported. |
At Week 0
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Number of Participants Receiving Concomitant IBD Medications
Prazo: Up to 96 weeks
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Participants receiving concomitant IBD medications for UC and CD will be reported. |
Up to 96 weeks
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Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
Prazo: Baseline (Week 0) up to 96 weeks
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The SIBDQ is a 10-item survey measuring HRQoL over the last 2 weeks (frequency of bowel movement, abdominal cramps, fatigue, lack of energy, worry of surgery, fear of no toilet, ability to relax, irritable, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL. |
Baseline (Week 0) up to 96 weeks
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Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scale Score
Prazo: Baseline (Week 0) up to 96 weeks
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The TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care. It consists of 9 items distributed in the domains: side effects, effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100, with higher score indicating higher treatment satisfaction. |
Baseline (Week 0) up to 96 weeks
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Change in Number of UC/CD Emergency Room Visits
Prazo: Baseline (Week 0) up to 96 weeks
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Change in the number of emergency room visits for treatment of UC/CD will be reported. |
Baseline (Week 0) up to 96 weeks
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Change in Number of UC/CD-Hospitalizations
Prazo: Baseline (Week 0) up to 96 weeks
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Change in the number of hospitalizations for treatment of UC/CD will be reported. |
Baseline (Week 0) up to 96 weeks
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Change in Number of UC/CD Surgeries
Prazo: Baseline (Week 0) up to 96 weeks
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Change in the number of surgeries for treatment of UC/CD will be reported. |
Baseline (Week 0) up to 96 weeks
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Change in C-Reactive Protein (CRP) Levels
Prazo: At Weeks 0, 4, 12, 48 and 96
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Change in CRP levels since guselkumab initiation will be reported. CRP is a marker of inflammation that will be measured by physicians following routine clinical practice. |
At Weeks 0, 4, 12, 48 and 96
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Change in Fecal Calprotectin (Fcal) Levels
Prazo: At Weeks 0, 4, 12, 48 and 96
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Change in Fcal levels since guselkumab initiation will be reported. The Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice. |
At Weeks 0, 4, 12, 48 and 96
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Number of Participants with Adverse events (AEs)
Prazo: Up to 96 weeks
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An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. |
Up to 96 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Janssen-Cilag S.A. Clinical Trial, Janssen-Cilag, S.A.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- CNTO1959IBD4010
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 www.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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