Clinical Prognosis and Progression of Myasthenia Gravis Patients

NCT ID: NCT04101578

Last Updated: 2021-08-23

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

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-08

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ocular MG

Patients with autoimmune MG whose symptoms restricted to extraocular muscles

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

Intervention Type DRUG

Treatment regimens are determined according to the physician's judgment and preferences of the patients.

Generalized MG

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

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

Intervention Type DRUG

Treatment regimens are determined according to the physician's judgment and preferences of the patients.

Interventions

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

Treatment regimens are determined according to the physician's judgment and preferences of the patients.

Intervention Type DRUG

Other Intervention Names

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Pyridostigmine Bromide, Prednisone, Methylprednisolone, Azathioprine, Tacrolimus, Cyclosporin A, Cyclophosphamide, Mycophenolate Mofetil, Methotrexate

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Da, Yuwei, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yuwei Da, M.D.

Role: STUDY_CHAIR

Xuan Wu Hospital, Capital Medical University

Locations

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Xuan Wu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yuwei Da, M.D.

Role: CONTACT

00-86-010-83198492

Facility Contacts

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yuwei Da, M.D.

Role: primary

00-86-010-83198492

Other Identifiers

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2017YFC0907705

Identifier Type: -

Identifier Source: org_study_id

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