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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age >18 years and<75 years;

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;

Disqualifiers

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;

Trial population

Patients with newly-onset ocular myasthenia gravis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Symptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil)

    Drug

    Treatment regimens are determined according to the physician's judgment and preferences of the patients.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with autoimmune ocular MG1 intervention

Trial outcomes

Primary outcomes

1

Conversion rate from ocular to generalized MG at the last follow-up visit.

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.

Time frame
144 weeks
2

Changes in the ratio of patients who achieve the level 2 of MG Status and Treatment Intensity (MGSTI) scale or better.

Ocular MG patients are followed up to determine the ratio of patients that achieve the status of MGSTI 2 or better at each period piont of follow-up. The clinical records will be retrospectively analyzed to search for risk factors prolonged the regimens reduction.

Time frame
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks
3

Changes in proportion of patients with treatment-related adverse events.

Treatment-Related Adverse Events (AEs) are evaluated in patients receiving different treatment protocol

Time frame
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks
4

Changes in scores of Quantitative Myasthenia Gravis (QMG) scale and of Absolute and Relative Score of MG(ARS-MG) scales from Baseline.

The improvement of clinic status of OMG patients was assessed by investigators according to QMG and ARS-MG score. 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.The ARS-MG is a 8-item scale which has a more detailed measure to assess ocular function . The total score ranges from 0 (no myasthenic findings) to 60 (maximal myasthenic deficits) obtained by summing the responses to each individual item.

Time frame
12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks

Secondary outcomes

1

Changes in titers of MG antibodies.

MG antibodies are detected at enrollment and the titers of antibodies will be monitored annually.

Time frame
Baseline, 48 weeks, 96 weeks, 144 weeks
2

Improvement of repeated frequency electrical stimulation tests (RNS) and single fiber electromyography (SFEMG).

RNS and SFEMG will be monitored on time to assess the clinic status.

Time frame
12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks
3

Relapse rate during follow-up period.

Ocular MG patients are followed up to determine the relapse rate at the end of follow-up. The clinical records will be retrospectively analyzed to search for risk factors of recurrence.

Time frame
Baseline, 144 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.