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

NCT07217509 | Enrolling By Invitation

• 1 other identifier: CorEvitas-MGR-720
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

• MG epidemiology

  The major clinical outcome include an assessment of the epidemiology of Myasthenia Gravis; to better understand the presentation and natural history. This will be determined using PROs and ClinROs which will be included as part of the case report forms.

  Every 6 months for 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are enrolled in the MG Registry during regularly scheduled office visits. Selected neurologists are invited to participate as investigators in the Registry.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 16, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)