Status:
ENROLLING_BY_INVITATION
PPDTM CorEvitasTM Myasthenia Gravis (MG) Drug Safety and Effectiveness Registry
Lead Sponsor:
CorEvitas
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18+ years
Brief 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 ...
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 c...
Eligibility Criteria
Inclusion
- To be eligible to participate in this registry, an individual must meet all the following criteria:
- Has been diagnosed with myasthenia gravis by a neurologist or a qualified neurology practitioner.
- Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
- Willing and able to provide informed consent.
- Willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, home address zip/postal code and email address or phone Number at a minimum) if required based on registry location and applicable laws and regulations.
- In addition, subject must meet at least one of the criteria:
- Have started taking a new Enrollment Eligible Medication within 12 months prior to the Enrollment visit. A new medication is a medication that the subject has never taken before.
- OR
- Is initiating (prescribed or starting) a new Enrollment Eligible Medication at the Enrollment visit. A new medication is a medication that the subject has never taken before.
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in the registry:
- Is participating or planning to participate in a double-blind clinical trial for a myasthenia gravis drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
Key Trial Info
Start Date :
August 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2099
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT07217509
Start Date
August 14 2025
End Date
December 31 2099
Last Update
October 16 2025
Active Locations (1)
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1
CorEvitas, LLC
Waltham, Massachusetts, United States, 02451