Tissue Repository for Studies of Myasthenia Gravis

NCT02902536 | Completed DMC

• 1 other identifier: IRB00078519
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

• Identification of New Antibodies in Myasthenia Gravis assessed by enzyme-linked immunosorbent assay (ELISA)

  Up to 2 years

Study Arms (3)

Myasthenia Positive Antibodies

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

Other: No interventions

Myasthenia Double Negative

Patients without AChR or MuSK antibodies

Other: No interventions

Normal Controls

Patients without myasthenia

Other: No interventions

Interventions

No interventions OTHER

Myasthenia Double Negative; Myasthenia Positive Antibodies; Normal Controls

Eligibility Criteria

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

Study Population

Patients with Myasthenia Gravis and normal controls

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 20817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will collect patient blood.

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: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 15, 2016
• Study Start: August 1, 2015
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)