RecruitingNCT04182984
TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study
Sponsor
Tang-Du Hospital
Enrollment
200 participants
Start Date
Nov 4, 2019
Study Type
OBSERVATIONAL
Conditions
Summary
This study collects the clinical data of new-onset ocular myasthenia gravis (OMG) patients, assesses outcomes and adverse effects of different treatment options, and evaluate risk factors of conversion to generalized MG(GMG).
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- Age >18 years and<75 years;
- Clinical Diagnosis of MG with supporting evidence:
- Patients with ocular muscle type MG who have never received treatment meet one of the diagnoses (1) and (2)-(5): (1) The patient's symptoms involve the extraocular muscles, except for drooping eyelids and diplopia, no other clinical symptoms; (2) unequivocal clinical response to pyridostigmine; (3) positive acetylcholine receptor antibody or musk antibody; (4) decrement of more than 10% in repetitive nerve stimulations study (RNS); (5) the "trembling" of the single fiber electromyography (SFEMG) is broadened with or without blockade;
- Willingness to sample collection, imaging study and other disease-related examinations and assessments;
- The results of pregnancy tests for female subjects with fertility during the screening period should be negative and effective contraception was used by the patient and her spouse during the study period;
- Patients with informed consent;
- Predicted survival time is longer than 3 years.
Exclusion Criteria13
- History of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue;
- Patients who may have other diseases that may lead to eyelid drooping, peripheral muscle weakness or diplopia;
- Age ≤18 years or ≥75 years;
- Patients who have been taking glucocorticoids or associated immunosuppressants due to other immune system diseases;
- Patients who cannot use immunosuppressants due to other chronic diseases;
- Patients who are unable to cooperate with follow-up and self-assessment due to severe mental illness or cognitive impairment;
- Pregnant women, lactating women and patients with fertility plans during the trial;
- Patients who have suffered from severe infections or malignant tumors in the last 1 month and are unable to receive immunosuppressants treatments;
- Patients who are not willing to cooperate with repeated frequency electrical stimulation tests and chest CT examinations;
- Patients who are not willing to participate in this study;
- Patients who are unable to sign informed consent;
- Predicted survival time is shorter than 3 years;
- Patients who are not suitable to participated in the trial after researchers' assessment.
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Interventions
DRUGSymptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil)
Treatment regimens are determined according to the physician's judgment and preferences of the patients.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04182984