Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving Clinical Response for UC as Measured by PMS
研究概览
简要总结
The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of 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 the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of 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
- •Must sign a 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
- •Has a 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
Group 1: 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
Number of Participants Achieving Clinical Response for UC as Measured by PMS
时间窗: Up to Week 96
Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical response for UC is defined as the PMS \<4 or \>=30 percent (%) reduction of baseline PMS.
Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
时间窗: Up to Week 96
HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical remission for CD is defined as the HBI score less than or equal to (\<=) 4.
Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
时间窗: Up to Week 96
Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical remission for UC is defined as the PMS score \<=2 and a rectal bleeding subscore of 0.
Number of Participants Achieving Clinical Response for CD as Measured by HBI
时间窗: Up to Week 96
HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical response for CD is defined as the HBI score less than or equal to (\<=) 4 or a decrease by greater than or equal to (\>=) 3.
Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI
时间窗: Up to Week 96
Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and HBI score \<=4. HBI score is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS
时间窗: Up to Week 96
Corticosteroid-free clinical remission for UC is defined as no use of steroids for at least 30 days and PMS \<2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI
时间窗: Up to Week 96
Corticosteroid-free clinical response for CD is defined as no use of steroids for at least 30 days and a reduction in HBI score by \>=3 points from baseline or achieving HBI score \<=4. HBI score is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS
时间窗: Up to Week 96
Corticosteroid-free clinical response for UC is defined as no use of steroids for at least 30 days and PMS \<4 or \>=30% reduction from baseline. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI
时间窗: Up to Week 96
Participants with corticosteroid-free remission by PRO-2 will be assessed. An abdominal pain (AP) score \<=1 and a mean stool frequency (SF) score \<=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days will be defined as a PRO-2 corticosteroid-free remission.
Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS
时间窗: Up to Week 96
Participants with corticosteroid-free remission by PRO-2 will be assessed. An SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding score of 0 with no use of corticosteroids for at least 30 days will be defined as a corticosteroid-free PRO-2 remission.
次要结局
- Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC(Baseline (at Week 0), Weeks 1, 2, 4, 8, 12)
- Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for CD(Baseline (at Week 0), Weeks 1, 2, 4, 8, 12)
- Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency(Baseline (at Week 0), Weeks 1, 2, 4, 8, 12)
- Time to Guselkumab Persistence(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 IBD Medication Use, Smoking Status and History, History of UC and History of CD(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: Comorbid Diagnoses(At Baseline)
- HRQoL as Measured by Bowel Urgency(Baseline (at Week 0), Weeks 12, 48 and 96)
- Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration(At Baseline)
- Number of Participants with CRP Normalization(At Week 0, 4, 12, 48 and 96)
- Change in Platelets Levels(At Week 0, 4, 12, 48 and 96)
- Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment(Baseline up to Week 96)
- 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 Fcal Normalization(At Week 0, 4, 12, 48 and 96)
- Change in C-reactive protein (CRP) Levels(Baseline up to Week 96)
- Change in Faecal Calprotectin (Fcal) Levels(Baseline up to Week 96)
- Change in Albumin Levels(At Week 0, 4, 12, 48 and 96)
- Change in Hemoglobin Levels(At Week 0, 4, 12, 48 and 96)
- Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score(Baseline (at Week 0), Weeks 12, 48 and 96)
- HRQoL as Measured by PRO-2 Components for Participants with CD(Baseline (at Week 0), Weeks 12, 48 and 96)
- HRQoL as Measured by PRO-2 Components for Participants with UC(Baseline (at Week 0), Weeks 12, 48 and 96)
- HRQoL as Measured by IBD-Control Questionnaire (ICHOM)(Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96)
- Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale(Baseline (Week 0), 12, 48, and 96)
- Number of Participants Achieving Endoscopic Response for 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 for Participants with CD as Measured by SES-CD(Baseline (at Week 0), Weeks 48 and 96)
- Number of Participants Achieving Endoscopic Improvement for Participants with UC as Measured by Mayo Score(Baseline (at Week 0), Weeks 48 and 96)
- Number of Participants Achieving Endoscopic Normalization for Participants with UC as Measured by Mayo Score(Baseline (at Week 0), Weeks 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 Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM)(Baseline (Week 0), Weeks 12, 48, and 96)
- Change in Number of UC/CD Emergency Room Visits(Baseline, Weeks 12, 48 and 96)
- Change in Number of UC/CD-Hospitalizations(Baseline, Weeks 12, 48 and 96)
- Change in Number of UC/CD Surgeries(Baseline, Weeks 12, 48 and 96)