NCT07602517尚未招募不适用
GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
This is an observational study of a prospective cohort of guselkumab-initiating Crohn's Disease (CD) and Ulcerative Colitis (UC) patients to identify new or incident spondyloarthritis. This study will include adult patients aged 18-75 with IBD who are undergoing guselkumab intravenous or subcutaneous induction over a 1-year timeframe.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Crohn's disease or Ulcerative Colitis disease based on confirmatory colonoscopy with biopsies, or if small bowel only, MRE with corresponding history
- •Age between 18 to 75 years old
- •Inflammatory bowel disease unclassified (IBD-U) subjects are eligible for inclusion if based on investigator assessment, the subject meets criteria for IBD-U, defined as chronic inflammatory bowel disease with overlapping features of Crohn's disease or ulcerative colitis
- •Initiating Guselkumab therapy in the next 30 days
- •Bio-naïve or bio-experienced* to ≤3 mechanisms of action *Defined as prior exposure or failure, as defined by inadequate efficacy or intolerance
排除标准
- •Unable to provide consent for participation
- •Known SpA diagnosis, prior to screening
- •Has started Guselkumab therapy
- •Prior exposure to IL-23 therapy (like Mirikizumab, Ustekinumab, etc.)
- •Prior exposure to TB, active or currently undergoing treatment for latent TB
- •Pregnancy as some pregnancy symptoms could be mistaken for SpA symptoms
- •Prior exposure to combination advanced biologic therapies
研究者
研究点 (1)
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