Different immunosuppressants and treatments for new-onset ocular myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational cohort collects real-world clinical data from adults with new-onset ocular myasthenia gravis at neurology departments across several hospitals in China. Investigators record clinical manifestations, laboratory results (including antibody testing), chest imaging, and thymectomy history, and collect peripheral blood samples annually. Treatment choices—including pyridostigmine, steroids, or immunosuppressants such as azathioprine, tacrolimus, or mycophenolate mofetil—are made by physicians together with patient preference, and patients are followed prospectively to monitor outcomes and adverse events. The study aims to enroll about 200 patients to compare treatment outcomes and identify risk factors for conversion to generalized myasthenia gravis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>18 years and\<75 years;
2. 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;
3. Willingness to sample collection, imaging study and other disease-related examinations and assessments;
4. 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;
5. Patients with informed consent;
6. Predicted survival time is longer than 3 years.

Exclusion Criteria:

1. History of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue;
2. Patients who may have other diseases that may lead to eyelid drooping, peripheral muscle weakness or diplopia;
3. Age ≤18 years or ≥75 years;
4. Patients who have been taking glucocorticoids or associated immunosuppressants due to other immune system diseases;
5. Patients who cannot use immunosuppressants due to other chronic diseases;
6. Patients who are unable to cooperate with follow-up and self-assessment due to severe mental illness or cognitive impairment;
7. Pregnant women, lactating women and patients with fertility plans during the trial;
8. Patients who have suffered from severe infections or malignant tumors in the last 1 month and are unable to receive immunosuppressants treatments;
9. Patients who are not willing to cooperate with repeated frequency electrical stimulation tests and chest CT examinations;
10. Patients who are not willing to participate in this study;
11. Patients who are unable to sign informed consent;
12. Predicted survival time is shorter than 3 years;
13. Patients who are not suitable to participated in the trial after researchers' assessment.

Where it's running

• Tangdu Hospotal
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Jun Guo, M.D.
• Email: guojun_81@163.com
• Phone: 86-29-8477 8844

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.