NCT07822529尚未招募不适用
GO-ON: Guselkumab lOngterm Persistency in Adult Patients With inflammatOry Bowel Disease: a Real World, National Non-iNterventional Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Persistence with Guselkumab Treatment
研究概览
简要总结
The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be greater than or equal to (>=) 18 years old
- •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. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)
- •Must have a confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative Colitis (UC) recorded in their medical records
- •Participant has received the information note/given his/her oral agreement and has not objected to the collection of their data
排除标准
- •Contraindicated to guselkumab per the label
- •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 a prior history of Stelara (ustekinumab) and biosimilars exposure, may be included
- •History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
研究组 & 干预措施
Guselkumab
Participants with confirmed diagnosis of moderate to severe crohn's disease (CD) or ulcerative colitis (UC) will be enrolled according to the approved local prescribing label and treated with guselkumab according to the local clinical practice. No drug will be provided as part of this study. Only data available from clinical practice will be collected within this study.
结局指标
主要结局
Persistence with Guselkumab Treatment
时间窗: Up to Week 96
Time to guselkumab discontinuation will be used to measure the guselkumab persistence in participants and is defined as the time from the first administration of guselkumab to its discontinuation date (defined as the date that the last dose of treatment was administered plus 1 dosing interval).
次要结局
- Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency(At Weeks 0, 1, 2, 4, 8, 12)
- Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with CD(At Weeks 0, 1, 2, 4, 8, 12)
- Number of Participants with Early Responses to Guselkumab Measured Using Simplified Patient-Reported Outcome (2-item) (PRO-2) Components in Participants with UC(At Weeks 0, 1, 2, 4, 8, 12)
- Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score(Up to Week 96)
- Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score(Up to Week 96)
- Number of Participants Achieving Corticosteroid-Free Clinical Response for CD as Measured by HBI Score(Up to Week 96)
- Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD(Up to Week 96)
- Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)(Up to Week 96)
- Number of Participants Achieving Clinical Remission for UC as Measured by PMS(Up to Week 96)
- Number of Participants Achieving Corticosteroid-Free Clinical Response for UC as Measured by PMS(Up to Week 96)
- Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC(Up to Week 96)
- Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD(Up to Week 96)
- Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC(Up to Week 96)
- Characteristics of Participants Receiving Guselkumab Treatment: Age(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Sex(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Usage(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Height(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Weight(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity At Index(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD(At Baseline)
- Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries(At Baseline)
- Number of Participants with Adverse Events (AE)(Up to Week 96)
- Change in C-Reactive Protein (CRP) Levels(Up to Week 96)
- Change in Fecal Calprotectin (Fcal) Levels(Up to Week 96)
- Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment(Up to Week 96)
- Health-related Quality of Life As Assessed by Short IBD Questionnaire (SIBDQ) Total Score(Up to Week 96)
- Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency(Up to Week 96)
- Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components(Up to Week 96)
- Functional Assessment Of Chronic Illness (FACIT) Fatigue (FACIT-F) Scale Score(Up to Week 96)
- Number of CD Participants Achieving Endoscopic Response as Measured by Simple Endoscopy Score-CD (SES-CD)(Up to Week 96)
- Number of Participants Achieving Endoscopic Remission in Participants with CD(Up to Week 96)
- Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score(Up to Week 96)
- Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score(Up to Week 96)
- Number of Participants Achieving Histological Improvement in Participants with UC as Measured by Nancy Score(Up to Week 96)
- Number of Participants Achieving Histological Remission in Participants with UC as Measured by Nancy Score(Up to Week 96)
- Number of Participants Achieving Intestinal Utrasound (IUS) Response in Participants with CD as Measured by Bowel Wall Thickness (BWT)(At Weeks 24, 48, 72, 96)
- Number of Participants Achieving IUS (Transmural) Remission in Participants with CD as Measured by BWT(At Weeks 24, 48, 72, 96)
- Number of Participants Achieving Magnetic Resonance Enterography (MRE) Response in Participants with CD(Up to Week 96)
- Number of Participants Achieving MRE Remission in Participants with CD(Up to Week 96)
- Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score(Baseline, Weeks 12, 48, and 96)
- Change from Baseline in Number of UC/CD Emergency Room Visits(Baseline, Weeks 12, 48, 96)
- Change from Baseline in Number of UC/CD Hospitalizations(Baseline, Weeks 12, 48, 96)
- Change from Baseline in Number of UC/CD Surgeries(Baseline, Weeks 12, 48, 96)
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