Tissue Repository for Studies of Myasthenia Gravis

NCT ID: NCT02902536

Last Updated: 2019-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-08-31

Brief Summary

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This is a study during which the investigators collect plasma and cells from patients with myasthenia gravis for the purpose of finding new antibodies.

Detailed Description

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This is a bio-specimen collection study. The investigators will collect plasma and peripheral lymphocytes. Plasma will be collected either when the patient undergoes plasma exchange, a decision independent of this study, or through a scheduled blood draw.

Patient plasma will be screened for novel antibodies which may cause myasthenia gravis. Subjects that are found to be positive for candidate antigens for myasthenia gravis will have a clinical evaluation which will consist of several disease rating scales will be performed (QMG score, MG-composite, Myasthenia Gravis Foundation of America (MGFA) clinical classification, MG-Quality of Life (QOL)15, MGFA Therapy Status).

Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Myasthenia Positive Antibodies

Patients with Acetyl choline receptor (AChR) or muscle-specific kinase (MuSK) Positive Myasthenia

No interventions

Intervention Type OTHER

Myasthenia Double Negative

Patients without AChR or MuSK antibodies

No interventions

Intervention Type OTHER

Normal Controls

Patients without myasthenia

No interventions

Intervention Type OTHER

Interventions

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No interventions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older.
* Clinical Diagnosis of MG with supporting evidence either from antibody testing, repetitive nerve stimulations study (RNS) or Single Fiber Electromyography (EMG) (SFEMG).

Exclusion Criteria

* Significant medical condition that would make participation in diagnostic and research part of evaluation impossible or risky. Acute or unstable medical condition.
* Inability to provide informed consent, either directly or via appointed power of attorney.
* Unwillingness to consent for collection of biological samples or their cryopreservation.
* Unable to provide evidence of previous antibody testing or neurophysiology confirming the diagnosis of Myasthenia Gravis.
* Any bleeding disorder that would prevent or present any danger during blood extraction.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00078519

Identifier Type: -

Identifier Source: org_study_id

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