NCT07541261招募中不适用
A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to Guselkumab Discontinuation
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 disease, 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
- •The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
- •The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
- •The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification
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 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 informed consent
研究组 & 干预措施
Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD): Guselkumab
Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from clinical practice, through routine therapeutic procedures and evaluation assessments will be collected within this study.
结局指标
主要结局
Time to Guselkumab Discontinuation
时间窗: Up to Week 96
Time to guselkumab discontinuation is defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion.
次要结局
- Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Crohn's Disease (CD)(Weeks 0, 1, 2, 4, 8, and 12)
- Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components for Ulcerative Colitis (UC)(Weeks 0, 1, 2, 4, 8, and 12)
- Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency(Weeks 0, 1, 2, 4, 8, and 12)
- Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI)(Weeks 12, 48 and 96)
- Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS)(Weeks 12, 48 and 96)
- Number of Participants Achieving Corticosteroid-free remission for UC(Weeks 24, 48 and 96)
- Number of Participants Achieving Corticosteroid-free remission for CD(Weeks 24, 48 and 96)
- Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC(Weeks 24, 48 and 96)
- Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD(Weeks 24, 48 and 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 Use(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 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 (AEs)(Up to Week 96)
- Change in C-reactive protein (CRP) Levels(Week 0, 12, 48 and 96)
- Change in Fecal Calprotectin (Fcal) Levels(Week 0, 12, 48 and 96)
- Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment(Baseline up to Week 96)
- Health-related Quality of Life As Assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score(Week 0, 12, 48 and 96)
- Health-related Quality of life of Participants Receiving Guselkumab Treatment as Assessed by Bowel Urgency(Week 0, 12, 48 and 96)
- Health-related Quality of Life of Participants Receiving Guselkumab Treatment as Assessed by PRO-2 Components(Week 0, 12, 48 and 96)
- Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score(Week 0 (Baseline) , Weeks 12, 48 and 96)
- Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)(Week 0, 12, 48 and 96)
- Number of Participants Achieving Endoscopic Remission in Participants with CD(Week 0, 12, 48 and 96)
- Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score(Week 0, 12, 48 and 96)
- Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score(Week 0, 12, 48 and 96)
- Change in Number of UC/CD Emergency Room Visits(Week 0, 12, 48 and 96)
- Change in Number of UC/CD-Hospitalizations(Week 0, 12, 48 and 96)
- Change in Number of UC/CD Surgeries(Week 0, 12, 48 and 96)
研究者
研究点 (1)
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