NCT04182984 TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study
| NCT ID | NCT04182984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tang-Du Hospital |
| Condition | Ocular Myasthenia Gravis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-11-04 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-11-04 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Jun Guo
STUDY CHAIR
Tangdu Hospital, Air Force Military Medical University
Frequently Asked Questions
Who can join the NCT04182984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ocular Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04182984 currently recruiting?
Yes, NCT04182984 is actively recruiting participants. Contact the research team at guojun_81@163.com for enrollment information.
Where is the NCT04182984 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT04182984 clinical trial?
NCT04182984 is sponsored by Tang-Du Hospital. The principal investigator is Jun Guo at Tangdu Hospital, Air Force Military Medical University. The trial plans to enroll 200 participants.