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临床试验/NCT07532213
NCT07532213招募中不适用

Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes

Janssen-Cilag A.G., Switzerland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月13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
50
试验地点
1
主要终点
Time to Guselkumab Persistence
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 guselkumab remains 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

  • •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 (but after treatment decision by physician)
  • •Must have 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 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 standard clinical practice and medical records will be collected.

结局指标

主要结局

Time to Guselkumab Persistence

时间窗: Up to Week 96

Persistence with guselkumab will be measured through time to discontinuation (defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion).

次要结局

  • Characteristics of Participants Receiving Guselkumab Treatment: Height(At Baseline)
  • Characteristics of Participants Receiving Guselkumab Treatment: Weight(Baseline (Week 0), Weeks 4, 8, 12, 48 and 96)
  • Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis(At Baseline)
  • Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components(Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12)
  • Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency(Baseline (at Week 0), Weeks 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 Clinical Remission for UC as Measured by PMS(Weeks 12, 48 and 96)
  • Number of Participants Achieving Clinical Remission for CD as Measured by HBI(Weeks 12, 48 and 96)
  • Number of Participants Achieving Clinical Remission for UC as Measured by PMS(Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI(Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS(Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI(Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD(Baseline (Week 0), Weeks 12, 48 and 96)
  • Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC(Baseline (Week 0), 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: Disease Duration(At Baseline)
  • Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity(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 Use(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)
  • Number of Participants with Drug-Related Adverse Events(Up to Week 96)
  • Number of Participants with Serious Adverse Events (SAE)(Up to Week 96)
  • Change in Leukocytes Count(Baseline (at Week 0), Weeks 4, 12, 48 and 96)
  • Number of Participants with Drug-Related Serious Adverse Events(Up to Week 96)
  • Number of Participants with C-reactive protein (CRP) Normalization(Baseline (at Week 0), Weeks 4, 12, 48 and 96)
  • Change in CRP Levels(Weeks 4, 12, 48 and 96)
  • Number of Participants with Fecal Calprotectin Normalization(Baseline (at Week 0), Weeks 4, 12, 48 and 96)
  • Change in Fecal Calprotectin Levels(Weeks 4, 12, 48 and 96)
  • Change in Hemoglobin Levels(Baseline (at Week 0), Weeks 4, 12, 48 and 96)
  • Change in Transferrin Saturation Levels(Baseline (at Week 0), Weeks 4, 12, 48 and 96)
  • Change in Ferritin Levels(Baseline (at Week 0), Weeks 4, 12, 48 and 96)
  • Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment(Baseline up to Week 96)
  • Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by PRO-2 Components for CD(Baseline (at Week 0), Weeks 24, 48, 72, and 96)
  • Change from Baseline in HRQoL as Measured by PRO-2 Components for UC(Baseline (at Week 0), Weeks 24, 48, 72, and 96)
  • Change from Baseline in HRQoL as Measured by Bowel Urgency(Baseline (at Week 0), Weeks 1, 2, 4, 8, 12, 24, 48, 72, and 96)
  • Changes from Baseline in HRQoL as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96)
  • Changes from Baseline in HRQoL as Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Questionnnaire(Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96)
  • Change from Baseline in HRQoL as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96)
  • Change from Baseline in HRQol as Measured by Work Productivity and Activity Questionnaire (WPAI)(Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96)
  • Change from Baseline in HRQoL as Measured by PROMIS Sleep Disturbance Short Form 8b (PROMIS 8b)(Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96)
  • Change from Baseline in HRQoL as Measured by Short-CONFIDE Survey for IBD (s-CS-IBD)(Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96)
  • Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)(Baseline (at Week 0), Weeks 48 and 96)
  • Number of Participants Achieving Endoscopic Remission in Participants with CD as Measured by SES-CD(Baseline (at Week 0), Weeks 48 and 96)
  • Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score(Baseline (at Week 0), Weeks 12, 48 and 96)
  • Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score(Baseline (at Week 0), Weeks 12, 48 and 96)
  • Number of Participants Achieving Histologic Improvement(At Weeks 0, 48 and 96)
  • Number of Participants Achieving Histologic Remission(At Weeks 0, 48 and 96)
  • Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response(Baseline (at Week 0), Weeks 24, 48, 72, and 96)
  • Number of Participants with CD Achieving IUS Remission(Baseline (at Week 0), Weeks 24, 48, 72, and 96)
  • Change from Baseline in Number of UC/CD Emergency Room Visits(Baseline (at Week 0), Weeks 12, 48 and 96)
  • Change from Baseline in Number of UC/CD-Hospitalizations(Baseline (at Week 0), Weeks 12, 48 and 96)
  • Change from Baseline in Number of UC/CD Surgeries(Baseline (at Week 0), Weeks 12, 48 and 96)

研究者

发起方
Janssen-Cilag A.G., Switzerland
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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