NCT07217509

PPDTM CorEvitasTM Myasthenia Gravis (MG) Drug Safety and Effectiveness Registry

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: CorEvitas · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The design is a prospective, observational (non-interventional) registry for subjects with myasthenia gravis under the care of a neurology provider. Longitudinal data are collected from both subjects and their treating neurology provider during routine clinical encounters using a structured and standardized data collection method. Approximately 1,500 myasthenia gravis subjects with no defined upper limit and 50 clinical neurology sites will be recruited.

Detailed description

The objective of the registry is to create a cohort of myasthenia gravis subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for myasthenia gravis. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of myasthenia gravis, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers.This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence

Conditions

• Myasthenia Gravis

Timeline

• Start date: 2025-08-14
• Primary completion: 2099-12-31
• Completion: 2099-12-31
• First posted: 2025-10-16
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States