TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study

Last updated: August 16, 2022
Sponsor: Tang-Du Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuropathy

Myasthenia Gravis Generalised

Sarcopenia

Treatment

N/A

Clinical Study ID

NCT04182984
2019TDSNOMG
  • Ages 18-75
  • All Genders

Study 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

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 thediagnoses (1) and (2)-(5): (1) The patient's symptoms involve the extraocular muscles,except for drooping eyelids and diplopia, no other clinical symptoms; (2) unequivocalclinical response to pyridostigmine; (3) positive acetylcholine receptor antibody ormusk antibody; (4) decrement of more than 10% in repetitive nerve stimulations study (RNS); (5) the "trembling" of the single fiber electromyography (SFEMG) is broadenedwith or without blockade;
  3. Willingness to sample collection, imaging study and other disease-related examinationsand assessments;
  4. The results of pregnancy tests for female subjects with fertility during the screeningperiod should be negative and effective contraception was used by the patient and herspouse during the study period;
  5. Patients with informed consent;
  6. Predicted survival time is longer than 3 years.

Exclusion

Exclusion Criteria:

  1. History of chronic degenerative, psychiatric, or neurologic disorder other than MGthat can produce weakness or fatigue;
  2. Patients who may have other diseases that may lead to eyelid drooping, peripheralmuscle weakness or diplopia;
  3. Age ≤18 years or ≥75 years;
  4. Patients who have been taking glucocorticoids or associated immunosuppressants due toother 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 severemental 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 1month and are unable to receive immunosuppressants treatments;
  9. Patients who are not willing to cooperate with repeated frequency electricalstimulation 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.

Study Design

Total Participants: 200
Study Start date:
November 04, 2019
Estimated Completion Date:
November 04, 2024

Study Description

This is a multicenter, observational cohort trial in the real-world clinical setting recruiting new-onset OMG patients from Neurology Departments of 7 hospitals in different regions of China. Clinical manifestations, laboratory test results, chest imaging and history of thymectomy are recorded. Treatment option 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. The investigators plan to recruit a final sample of 200 patients for analysis.

Connect with a study center

  • Tangdu Hospotal

    Xi'an, Shaanxi
    China

    Active - Recruiting

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