Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 496
- 试验地点
- 1
- 主要终点
- Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic)
研究概览
简要总结
The IDEaL registry is a cooperative, observational registry focused on immunoglobulin use in the U.S. The registry is a deliberate and purposeful assembly of clinical and humanistic knowledge that is intended to act as a longitudinal database, tracking outcomes of routine clinical practice.
The central goal of the registry is to provide a mechanism that allows for a better understanding of how immunoglobulin therapy is being used in a real-world clinical setting. The data gathered will help the industry gain a better understanding surrounding the therapeutic value of immunoglobulin therapy and subsequently improve practices, reduce medical costs, and ultimately improve the clinical outcomes for the patients receiving immunoglobulin therapy
详细描述
The registry's goal is to significantly contribute to the medical understanding of Ig therapy and to improve the quality of care for patients receiving Ig therapy in the United States through active publication of registry findings and disease management approaches.
The IDEaL program represents a unique and powerful method for the collection of:
Patient Level / Humanistic Data / Quality of Life Physician Level / Practice Patterns Clinical Data / Therapeutic Outcomes Reimbursement / Impact on Treatment / Policy Decisions
Whereby:
Accelerating innovation Producing faster knowledge gains Improving awareness of patient outcomes and disease burden Providing a clearer understanding of therapy impact on patients' quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Any age, disease, or gender requiring Ig therapy
- •Agree to the use of Coram's infusion services after entry into IDEaL Registry
排除标准
- •Unable to start, or stops taking Ig therapy
- •Use of an insurance provider for which Coram's services are not covered/authorized.
- •Have previously participated in the IDEaL Registry and revoked consent to use their PHI
结局指标
主要结局
Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic)
时间窗: Baseline
Recorded from referral form
Infection incidence by route, dose, and age
时间窗: every 6 months
Infection incidence, route, dose recorded from Clinical Progress reports Immune Replacement Efficacy section
次要结局
- Dosing information by disease type, Investigative Site, and therapeutic indication(Estimated for baseline and 1 year)
- Adverse events and serious adverse events by disease type and relation to Ig therapy(Estimated for baseline and 1 year)
- Current state of disease by number of Ig doses received and overall(Estimated for 1 year)
- IVIg vs SCIg by disease type and geographic region (and/or investigative site)(Baseline)
- Insurance reimbursement issues(Estimated for baseline and 1 year)
- Payor type by investigator site(Estimated for baseline and 1 year)
- Concomitant medication use by disease type and therapeutic indication(Estimated for baseline and 1 year)