CorEvitas Multiple Sclerosis (MS) Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events (AEs) or serious adverse events (SAEs).
研究概览
简要总结
This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for MS in a cohort of patients cared for by neurologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.
详细描述
The objective of the CorEvitas Multiple Sclerosis (MS) Registry is to create a national cohort of patients with MS. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of MS. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the prevalence and incidence of comorbidities and adverse events, medication utilization patterns and patient productivity measures.
The design is a prospective, non-interventional, observational registry for patients with MS under the care of a licensed neurologist. Longitudinal follow-up data is collected from both patients and their treating neurologist (also known as "Providers" for a CorEvitas registry study) every 6 months (+/- 30 days) during routine clinical encounters using CorEvitas registry forms. These forms collect data on patient demographics, disease duration, medical history (including all prior and current treatments for MS), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes. After the enrollment visit, MS patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals. Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.
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
- •Has a diagnosis of MS at the time of enrollment.
- •Age 18 years or older at the time of enrollment.
- •Willing to provide Personal Information.
- •Initiating (prescribed or starting) an Eligible Medication for the treatment of MS at the enrollment visit.
排除标准
- •1) Is participating or planning to participate in a double-blind randomized trial for an MS drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
研究组 & 干预措施
Multiple Sclerosis
Multiple Sclerosis Pts presenting to enrolling sites across the US are invited to enroll if eligible
结局指标
主要结局
Number of patients with adverse events (AEs) or serious adverse events (SAEs).
时间窗: Time Frame: A minimum of 10 years from last patient enrolled
Targeted events include malignancy, anaphylaxis, cardiovascular disease, serious infection, autoimmune disease, MS Relapse, hepatic events, and general serious adverse events. An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Physician reported: Symbol Digit Modalities Test (SMDT)(Time Frame: every 6 months for 10 years)
- Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)(Time Frame: every 6 months for 10 years)
- Patient reported: Patient Clinical Global Impression (PCGI) Scale(Time Frame: every 6 months for 10 years)
- Disease burden: Relapse Information(Time Frame: every 6 months for 10 years)
- Physician reported: Nine-Hole Peg Test (9-HPT)(Time Frame: every 6 months for 10 years)
- Patient reported: MS Disability Score29(Time Frame: every 6 months for 10 years)
- Percentage of patients with history of comorbidities(Time Frame: at registry enrollment)
- Patient reported: Patient reported :MS Quality of Life, MSIS-29(Time Frame: every 6 months for 10 years)