Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocular MG | Patients with autoimmune MG whose symptoms restricted to extraocular muscles |
| |
| Generalized MG | Patients not only suffer from extraocular muscles weakness but also from limb weakness, bulbar symptoms, or even respiratory failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg) | Drug | Treatment regimens are determined according to the physician's judgment and preferences of the patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rates from ocular to generalized MG at the last visit and risk factors. | Ocular MG patients are followed up to determine the ratio of conversion to generalized disease at the end of follow-up. The clinical records will be retrospectively analyzed to search for risk factors of progressing. | Baseline, 48 months |
| Change in Quantitative Myasthenia Gravis (QMG) Scores from Baseline to 48 months. | The QMG is a 13-item scale which measures ocular, bulbar, limb function and respiratory function. The total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) obtained by summing the responses to each individual item (None=0, Mild=1, Moderate=2, Severe=3). | Baseline, 12 months, 24 months, 36 months, 48 months |
| Change in MG-specific Activities of Daily Living scale (MG-ADL). | The MG-ADL is an 8-item scale to assess symptoms of myasthenia gravis patients obtained by summing the responses to each individual item (Grades: 0,1,2,3). The score ranges from 0 to 24. | Baseline,3months, 6 months, 9 months, 12 months, 18 months, 24 months, 30months, 36 months, 42 months, 48 months |
| The proportion of patients reaching minimal manifestations (MM) or better. | Clinical statuses of patients are assessed and categorized according to Myasthenia Gravis Foundation of America (MGFA) postintervention status (PIS). MM or better includes Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients with Treatment-related Adverse Experiences. | Treatment-Related Adverse Events (AEs) are evaluated in patients of different regimens. | 3 months, 6 months, 12 months, 24 months, 36 months, 48 months |
| Changes in titers of MG antibodies. |
Not provided
Inclusion Criteria:
Age >14.
Clinical Diagnosis of MG with supporting evidence:
Willingness to sample collection, imaging study and other disease-related examinations and assessments.
Patients with informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with Myasthenia Gravis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuwei Da, M.D. | Contact | 00-86-010-83198492 | dayuwei1000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| yuwei Da, M.D. | Xuan Wu Hospital, Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuan Wu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
Not provided
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013256 | Steroids |
| D007166 | Immunosuppressive Agents |
| D016756 | Immunoglobulins, Intravenous |
| D011729 | Pyridostigmine Bromide |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| D001379 | Azathioprine |
| D016559 | Tacrolimus |
| D016572 | Cyclosporine |
| D003520 | Cyclophosphamide |
| D009173 | Mycophenolic Acid |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
Not provided
Not provided
Not provided
Peripheral blood samples are collected annually.
|
MG antibodies are detected at enrollment and the titers of antibodies will be monitored annually. |
| Baseline, 12 months, 24 months, 36 months, 48 months |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018942 | Macrolides |
| D007783 | Lactones |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |