Exploring Outcomes and Characteristics of Myasthenia Gravis 2

NCT06002945 | Completed DMC

• 2 other identifiers: 20000269201U54NS115054-01
• Study Type: observational
• Target: 311
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this prospective observational study is to create a network repository of clinical data and biological samples to help researchers learn more about myasthenia gravis.

Conditions

Myasthenia Gravis

Keywords

Neuromuscular; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Muscle weakness; Autoimmune Diseases; Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• The number of participants enrolled and serial blood reported at the conclusion of the enrollment period.

  5 years

Study Arms (1)

Neurological Outpatients

Participants in this group will be recruited from the outpatient clinical population at MGNet participating sites. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.

Other: Blood sample

Interventions

Blood sample OTHER

Each blood draw will involve removing approximately 75 mL (5 tablespoons) of blood

Neurological Outpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.

You may qualify if:

• Diagnosed with MG based on clinical presentation and seropositivity for MG associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a decremental response on repetitive nerve stimulation, positive single fiber electromyography (EMG) or positive edrophonium test. Signs and symptoms should not be better explained by another disease process.
• A) Diagnosed with MG within 2 years of study enrollment and with adequate records to document MG history (e.g., onset, MG meds) prior to enrollment at the discretion of the investigator.
• or B) MuSK antibody, LRP4 antibody, or thymoma-associated MG at any point in the disease course. Patients with a diagnosis of MG more than 2 years prior to the first study visit who are expected to undergo a thymectomy may also be enrolled.
• Participant has the capacity to understand and sign a written informed consent form.
• Participant must be willing to complete the study and return for follow-up visits.

You may not qualify if:

• A history of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue that would confound outcome measure assessments or any disorder that interferes with participation in this protocol.
• Participant is unable or unwilling to comply with the study procedures.
• Treatment with any investigational agent within 4 weeks of the baseline visit or 5 half-lives of the investigational drug (whichever is longer).
• If an EXPLORE-MG2 participant is later enrolled in an interventional trial, it will be at the investigator's discretion whether to continue collecting biosamples while the patient is participating in the interventional trial. Collection of natural history data should continue.
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates or that may affect the interpretation of the results or render the participant not an appropriate study participant.

Sponsors & Collaborators

• Yale University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (10)

University of California-Irvine

Irvine, California, 92697, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Myasthenia Gravis; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Muscle Weakness; Autoimmune Diseases; Immune System Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richard Nowak, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Vern Juel, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: January 12, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)