NCT05809583撤回不适用
Applying Precision Medicine to Define Predictors of Response to Ozanimod and Discovering Biomarkers in the Management of Ulcerative Colitis Using 7,000 Protein SOMAscan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.
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
- •Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
- •Patients with moderate to severe UC, determined by a 3-component Mayo score of 5-9 with an endoscopic subscore ≥ 2.Endoscopy must be performed within 90 days of ozanimod initiation
- •Elevated CRP (greater than upper limit of normal on assay) and/or fecal calprotectin (>250 mcg/g) within 90 days of drug initiation
排除标准
- •Diagnosis of Crohn's disease or indeterminate colitis
- •Total (procto)colectomy
- •Ileoanal pouch anastomosis
- •Current ileostomy or colostomy
- •Untreated Clostridium difficile infection
- •Known pregnancy
研究组 & 干预措施
ozanimod
Patients with UC starting ozanimod therapy as part of their clinical care
干预措施: Ozanimod (Drug)
结局指标
主要结局
Clinical response
时间窗: 10 weeks
The primary endpoint measure is clinical response defined as a decrease of at least 50% in PRO2 at week 10 (end of induction)
次要结局
- Clinical response(22 weeks)
- Clinical remission(10 weeks)
- Fecal calprotectin(2, 10, 22 weeks)
- CRP(2, 10, 22 weeks)
- Corticosteroid free remission(22 weeks)
研究者
Laurie Grossberg
Instructor in Medicine
Beth Israel Deaconess Medical Center
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC TestGastric CancerNCT06521528Novomics. Co., Ltd.237
招募中
不适用
Identification of predictive biomarkers for treatment outcome in patients with advanced hepatocellular carcinomaDiseases of the digestive systemKCT0002264Yonsei University Health System, Severance Hospital100
已完成
不适用
Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric CancerEsophageal NeoplasmsStomach NeoplasmsNCT02305043University of Leipzig549
进行中（未招募）
1 期
prediction of response to therapy in inflammatory bowel diseaseEUCTR2018-002925-47-ESFundación de Investigación Biomédica del Hospital Universitario de La Princesa180
终止
不适用
Biomarkers for Dexamethasone Response in Sars-Cov-2 / COVID-19 PneumoniaPneumonia, ViralSARS-Cov-2NCT04619693University Hospital, Montpellier79