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临床试验/NCT07606339
NCT07606339招募中不适用

Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis

Janssen-Cilag Pharma GmbH1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年6月10日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
35
试验地点
1
主要终点
Persistence with Guselkumab Treatment
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) 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 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 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
  • •Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
  • •Must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements

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)

Participants with confirmed diagnosis of moderate to severe crohn's disease (CD) or ulcerative colitis (UC) treated with guselkumab in routine clinical practice will be enrolled. No drug will be provided as a part of this study. Only data available from clinical practice and medical records 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

Persistence with guselkumab treatment is defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion. It will be used to measure the guselkumab persistence in participants.

次要结局

  • Change from Baseline in Number of UC/CD Surgeries(At Weeks 0 (baseline), 12, 48, 96)
  • Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency(At Weeks 0 (baseline) 1, 2, 4, 8 and 12)
  • Number of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) Components(At Weeks 0 (baseline), 1, 2, 4, 8 and 12)
  • Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Clinical Remission for CD as Measured by HBI Score(At Weeks 12, 48 and 96)
  • Characteristics of Participants Receiving Guselkumab Treatment: Height(At Baseline)
  • Number of Participants Achieving Clinical Remission for UC as Measured by PMS(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free Clinical Response for CD(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free Clinical Response for UC(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free Clinical Remission for CD(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free Clinical Remission for UC(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD(At Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC(At Weeks 12, 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: Smoking Status and History(At Baseline)
  • Characteristics of Participants Receiving Guselkumab Treatment: Weight(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: Disease Severity At Index(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 Inflammatory Bowel Disease (IBD) Medication Usage(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)
  • Number of Participants with Drug-Related AE(Up to Week 96)
  • Number of Participants with Serious Adverse Events (SAE)(Up to Week 96)
  • Number of Participants with Drug-Related SAEs(Up to Week 96)
  • Number of Participants with C-Reactive Protein (CRP) Normalization(At Weeks 0 (baseline), 4, 12, 48 and 96)
  • Change in CRP Levels(At Weeks 4, 12, 48 and 96)
  • Number of Participants with Fecal Calprotectin (fCAL) Normalization(At Weeks 0 (baseline), 4, 12, 48 and 96)
  • Change in fCAL Levels(At Weeks 4, 12, 48 and 96)
  • Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment(Up to Week 96)
  • Change from Baseline in Health-Related Quality of life (HR-QoL) as Measured by Bowel Urgency(At Weeks 0 (baseline), 4, 8,12, 24, 48, 72, 96)
  • Change from Baseline in HR-QoL of Participants with CD Receiving Guselkumab Treatment as Measured by PRO-2 Components(At Weeks 0(baseline), 4, 8,12, 24, 48, 72, 96)
  • Change from Baseline in HR-QoL of Participants with UC Receiving Guselkumab Treatment as Measured by PRO-2 Components(At Weeks 0 (baseline), 4, 8,12, 24, 48, 72, 96)
  • Changes from Baseline in HRQoL as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(At Weeks 0 (baseline), 12, 48, 96)
  • Changes from Baseline in HRQoL as Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Questionnaire(At Weeks 0 (baseline), 12, 48, 96)
  • Change from Baseline in Satisfaction with Guselkumab Treatment as per Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score(At Weeks 0 (baseline), 12, 48, 96)
  • Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)(Up to Week 96)
  • Number of Participants Achieving Endoscopic Remission in Participants with CD as Measured by SES-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(Up to Week 96)
  • Number of Participants Achieving Histological Remission in Participants with UC(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 0 (baseline), 24, 48, 72 and 96)
  • Number of Participants Achieving IUS (Transmural) Remission in Participants with CD as Measured by BWT(At Weeks 0 (baseline), 24, 48, 72 and 96)
  • Change from Baseline in Number of UC/CD Emergency Room Visits(At Weeks 0 (baseline), 12, 48, 96)
  • Change from Baseline in Number of UC/CD Hospitalizations(At Weeks 0 (baseline), 12, 48, 96)

研究者

发起方
Janssen-Cilag Pharma GmbH
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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