Myasthenia GravisNCT07217509
PPDTM CorEvitasTM Myasthenia Gravis (MG) Drug Safety and Effectiveness Registry
An observational study of Myasthenia Gravis, run by CorEvitas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 31 Dec 2099
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Medical subject headings
- Myasthenia Gravis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 6 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start14 Aug 2025
- Primary completion31 Dec 2099 (estimated)
- Study completion31 Dec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217509
- Sponsor's protocol ID
- CorEvitas-MGR-720
- Status last verified
- Oct 2025
- First submitted
- 8 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPDTM CorEvitasTM Myasthenia Gravis (MG) Drug Safety and Effectiveness Registry
- ClinicalTrials.gov ID
- NCT07217509
- Acronym / sponsor ID
- CorEvitas-MGR-720
- Conditions
- Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Dec 2099 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- To be eligible to participate in this registry, an individual must meet all the following criteria:
- OR
Key exclusion criteria (2 listed)
- An individual who meets any of the following criteria will be excluded from participation in the registry:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MG epidemiology
Time frame: Every 6 months for 10 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Myasthenia Gravis
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MG epidemiology (time frame: Every 6 months for 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.