Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 8
- 主要终点
- The Vitaccess Real MG Registry
研究概览
简要总结
Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records.
Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.
详细描述
Traditional site recruitment (all countries):
Adult patients who are being treated for MG at one of the participating clinics or centers in one of the participating countries (currently the US and UK) at the time of enrolment and who meet the inclusion and exclusion criteria will be identified and approached by their clinical team and invited to participate in the registry.
Patient-reported data will be collected via the VRMG Registry platform, a digital data capture platform accessible via any web-enabled platform (e.g., phone, tablet, laptop, computer). Custom survey and patient-reported outcomes data will be collected at baseline and at regular intervals thereafter for a follow-up period of up to 10 years. The data collected will capture the impact of MG on daily living, fatigue, and health-related quality of life.
Site research teams will complete and update an eCRF (every six months ± one months) for each patient, including data from the patient's EMR. eCRFs that are completed within one months prior to or following each six-month mark will be considered within the same assessment window for analytics purposes so that patients will not be required to visit the clinical site for the purposes of the registry outside of their regular clinical visits.
Community neurologist recruitment (US only):
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- •Adult (age ≥18 years) with a clinically-confirmed diagnosis of myasthenia gravis (MG).
- •Resident in one of the scope countries.
- •Access to a smartphone/tablet/computer/laptop
- •Willing and able to provide informed consent in their local language to take part in the study.
排除标准
- •Participation in a clinical trial at the time of study enrolment.
结局指标
主要结局
The Vitaccess Real MG Registry
时间窗: 10 years
A patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life.
次要结局
- Describe the demographic characteristics of patients(At baseline)
- Describe change in clinical trial participation of patients(At follow-up visits (every 6±1 months) for up to 10 years)
- Describe the diagnosis (date, tests, and symptoms) of patients(At baseline)
- Describe change in clinical characteristics of patients.(At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years)
- Describe change in medical history of patients(At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years)
- Describe change in concomitant treatments received by patients(At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years)
- Describe change in routine MG treatments received by patients(At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years)
- Describe change in rescue MG treatments received by patients(At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years)
- Describe change in severity of MG symptoms experienced by patients(At baseline and every 1 month thereafter for up to 10 years.)
- Describe change in healthcare resource use of patients(At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years)
- Describe change in type and severity of adverse events experienced by patients(At follow-up visits (every 6±1 months) for up to 10 years)
- Describe change in type and severity of fatigue experienced by patients(At baseline and every 2 months thereafter for up to 10 years.)
- Describe change in impact of MG on health-related quality of life of patients(At baseline and every 2 months thereafter for up to 10 years.)