Clinical Prognosis and Progression of Myasthenia Gravis Patients

Da, Yuwei, M.D.

Status: Enrolling

Conditions: Myasthenia Gravis

Treatments: Drug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)

Study type: Observational

Identifiers

NCT04101578

2017YFC0907705

Details and patient eligibility

About

This study collects the clinical data of myasthenia gravis (MG) patients, assesses outcomes and adverse effects of different treatment regimens, and searches for risk factors of conversion to generalized MG.

Full description

This is a multicenter, observational cohort trial in the real-world clinical setting recruiting MG patients from Neurology Departments of 6 hospitals in different regions of China. Clinical manifestations, laboratory test results, chest imaging and history of thymectomy are recorded. Patients will be classified by clinical manifestation as well as antibody status, and treatment regimens are determined according to the physician's judgment and preferences of the patients. Patients are followed up prospectively on regular to assess the outcomes of treatments and monitor any side effects. Peripheral blood samples are collected annually. Patients' clinical records are uploaded to an online database. The investigators plan to recruit a final sample of 2000 patients for analysis.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >14.

2. Clinical Diagnosis of MG with supporting evidence:

   1. unequivocal clinical response to pyridostigmine
   2. positive antibody testing
   3. decrement >10% in repetitive nerve stimulations study (RNS) .

3. Willingness to sample collection, imaging study and other disease-related examinations and assessments.

4. Patients with informed consent.

Exclusion criteria

1. History of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue.
2. Age ≤14 years.
3. Severe anxiety, depression or schizophrenia.
4. Cognitive impairment or mini-mental state examination (MMSE) score ≤24.
5. Severe systemic illness with life-expectancy less than 4 years.
6. Unwillingness to consent for collection of biological samples.
7. Inability to provide informed consent.

Trial design

2,000 participants in 2 patient groups

Ocular MG

Description:

Patients with autoimmune MG whose symptoms restricted to extraocular muscles

Treatment:

Drug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)

Generalized MG

Description:

Patients not only suffer from extraocular muscles weakness but also from limb weakness, bulbar symptoms, or even respiratory failure

Treatment:

Drug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)