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).
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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Santiago de Compostela, España, 15706
- Hosp. Clinico Univ. de Santiago
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: OTHER
Cohortes e Intervenciones
Grupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Persistence of Treatment with Guselkumab
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
- Director de estudio: Janssen-Cilag S.A. Clinical Trial, Janssen-Cilag, S.A.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CNTO1959IBD4010
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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