Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving a Clinical Response (CR) on at Least one Extra-intestinal Manifestation/Immune-mediated Inflammatory Disease (EIM/IMID) Associated with Inflammatory Bowel Disease (IBD) at Week 24
研究概览
简要总结
The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's Disease [CD] and Ulcerative Colitis [UC]).
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
- •With a confirmed diagnosis of CD or UC
- •With at least one EIM of interest (cutaneous: pyoderma gangrenosum; erythema nodosum, articular: axial spondyloarthritis and peripheral spondyloarthritis with and without psoriasis, dactylitis, enthesitis; ocular: uveitis) and/or at least one IMIDs of interest (cutaneous: psoriasis, atopic dermatitis, hidradenitis suppurativa), suspected or confirmed, that is active at the time of screening
- •Starting ustekinumab as a biologic therapy for CD or UC treatment independently of their enrollment into the study
- •Using ustekinumab according to the SmPC
- •Only for participants with CD: has had an inadequate response with or lost response to or be intolerant to conventional therapy including azathioprine, 6-mercaptopurine or corticosteroids or; at least one tumor necrosis factor (TNF) blocker (adalimumab, infliximab). Only for participants with UC: Have had an inadequate response with, lost response to, or were intolerant to either conventional including azathioprine, 6-mercaptopurine or corticosteroids or a biologic
排除标准
- •Participants suffering from a psoriasis induced by a biological therapy at inclusion (including TNF blocker) or participant presenting an active psoriasis that was diagnosed before the time of inflammatory bowel disease (IBD) diagnosis
- •Participants currently enrolled in an investigational study (or have been in the past 2 months) or are unwilling or not able to understand or provide their consent
研究组 & 干预措施
Inflammatory Bowel Disease (IBD) Participants with EIMs and/or IMIDs
IBD (Crohn's Disease [CD] or Ulcerative Colitis [UC]) participants with suspected extra-intestinal manifestations (EIMs) and/or one or more immune-mediated inflammatory diseases (IMIDs) will be enrolled into the study to assess effectiveness of ustekinumab on EIMs and/or IMIDs associated with IBD (both CD and UC). Participants will receive ustekinumab at study entry (Week 0) as treatment for IBD according to standard clinical practice and will be followed up to 24 weeks (+/- 3 weeks). Only data available per clinical practice will be collected within this study.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Clinical Response (CR) on at Least one Extra-intestinal Manifestation/Immune-mediated Inflammatory Disease (EIM/IMID) Associated with Inflammatory Bowel Disease (IBD) at Week 24
时间窗: Week 24
CR will be determined based on the measures collected by the investigators which will be assessed by the specialists based on these parameters: 2 points reduction in physician global assessment (PGA) score or PGA 0 or 1 (0= clear to 5=very severe) achieved for cutaneous disease, or resolution of lesions for Erythema nodosum (dermatology); decrease of 50 percent (%) of ankylosing spondylitis disease activity index (BASDAI) (1=no problem to 10=worst problem) for axial spondyloarthritis (SpA); disease activity score (DAS)28 (derived from 4 items with score \<2.6 \[disease remission\] and \>5.1 \[severe disease activity\]) of moderate and good response achieved in peripheral SpA plus 2 points reduction in PGA score or PGA 0 or 1 achieved in case of associated psoriasis; resolution of dactylitis, decrease of 50% of Leeds enthesitis index \[LEI-6\] score which ranges from 0 \[pain/tenderness absent\] to1 \[pain/tenderness present\] for enthesitis, (rheumatology); resolution of uveitis (ophthalmology).
次要结局
- Percentage of Participants with Change from Baseline in Clinical Response for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)(Baseline, Week 16 and Week 24)
- Percentage of Participants Achieving Remission for CD as Measured by HBI(Up to Week 24)
- Short Inflammatory Bowel Disease Questionnaire Score (Short IBDQ)(Baseline, Weeks 16 and 24)
- Percentage of Participants Achieving Remission for UC as Measured by Partial Mayo Score (Score of <=2)(Up to Week 24)
- Change from Baseline in Partial Mayo Score(Baseline, Week 16 and Week 24)
- Work Productivity and Activity Impairment (WPAI) Questionnaire(Baseline, Weeks 16 and Week 24)
- Change from Baseline in the Presence of Extra Intestinal Manifestations (EIMS) or Immune-Mediated Inflammatory Diseases (IMIDs)(Baseline and Week 24)
- Functional Assessment of Chronic Illness Therapy Scale (FACIT)(Baseline, Weeks 16 and 24)
- Inflammatory Bowel Disease-Disability Index (IBD-DI)(Baseline, Weeks 16 and 24)
- Number of Participants with Adverse Events(Up to 37 weeks)
- Number of IBD Related Medical Visits(Week 24)
- Number of Days of IBD Related Hospitalization with Surgery(Week 24)
- Number of Days of IBD Related Hospitalization Without Surgery(Week 24)
- Number of IBD Related Emergency Visits(Week 24)