INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Proportion of Patients Requiring an Increase in IBD Disease Management
研究概览
简要总结
The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.
The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States.
The main questions it aims to answer are:
- Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)?
- Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy?
- Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization.
Participants will:
- Receive either mirikizumab or standard biologic therapy as part of routine clinical care
- Attend follow-up visits at approximately 3, 6, 12, and 18 months
- Have clinical data collected from electronic health records and healthcare utilization sources
- Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning
- Undergo routine laboratory tests and clinical assessments as part of standard care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years at the time of enrollment
- •Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD)
- •Eligible for treatment with biologic therapy for IBD, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists)
- •No prior exposure to mirikizumab and no contraindications to mirikizumab
- •Ability to provide informed consent
- •Willingness to comply with study procedures and follow-up requirements
排除标准
- •Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab)
- •Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators)
- •Participation in an interventional clinical trial within 90 days prior to enrollment
- •History of extensive colorectal resection, including:
- •Total proctocolectomy (for UC), or
- •Surgical removal of two or more intestinal segments (for CD)
- •Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study
研究组 & 干预措施
Mirikizumab Clinical Care Pathway
Participants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice. Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care.
干预措施: Mirikizumab (Drug)
Standard Biologic Therapy Clinical Care Pathway
Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.
干预措施: IL-12 (Drug)
Standard Biologic Therapy Clinical Care Pathway
Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.
干预措施: anti-integrin antibodies (Drug)
Standard Biologic Therapy Clinical Care Pathway
Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.
干预措施: Anti-TNF agents (Drug)
Standard Biologic Therapy Clinical Care Pathway
Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.
干预措施: IL-23 (Drug)
结局指标
主要结局
Proportion of Patients Requiring an Increase in IBD Disease Management
时间窗: Up to 18 months following initiation of therapy
The proportion of patients requiring an increase in inflammatory bowel disease (IBD) disease management, defined as a composite of treatment and healthcare resource use, while receiving index therapy.
次要结局
- Change in Disease Activity Measured by Crohn's Disease PRO2 Scores(Baseline, 6 months, 12 months, and 18 months)
- Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores(Baseline, 6 months, 12 months, and 18 months)
- Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD)(Up to 18 months (as available from routine clinical care))
- Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score.(Up to 18 months (as available from routine clinical care))
- Treatment Persistence(Up to 18 months)
- Proportion of Patients with Dose Escalation(Up to 18 months)
- Time to Next Treatment(Up to 18 months)
- Concomitant Medication Use(Baseline through 18 months)
- Corticosteroid-Free Time(Up to 18 months)
- Healthcare Resource Utilization(Up to 18 months)
- Change in Patient-Reported Outcomes Measured by SIBDQ(Baseline, 6 months, 12 months, and 18 months)
- Change in Patient-Reported Outcomes Measured by UNRS(Baseline, 6 months, 12 months, and 18 months)
- Change in Patient-Reported Outcomes Measured by PROMIS Global Health(Baseline, 6 months, 12 months, and 18 months)
- Change in Patient-Reported Outcomes Measured by SAA(Baseline, 6 months, 12 months, and 18 months)
- Change in Patient-Reported Outcomes Measured by WPAI:SHP(Baseline, 6 months, 12 months, and 18 months)
- Proportion of Participants Achieving Clinical Remission Based on Ulcerative Colitis PRO2.(Baseline, 6 months, 12 months, and 18 months)
- Proportion of Participants Achieving Clinical Remission Based on Crohn's Disease PRO2.(Baseline, 6 months, 12 months, and 18 months)