An observational study in Myasthenia Gravis, sponsored by Da, Yuwei, M.D.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Da, Yuwei, M.D. · Observational
The goal of this observational study is to evaluate the efficacy and safety of consolidation therapy with corticosteroids and/or immunosuppressants combined with efgartigimod in patients with generalized myasthenia gravis after the acute exacerbation.
324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.
This study's planned enrollment of 130 is close to the median of 140 across 104 observational studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →Da, Yuwei, M.D. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
AChR antibody-positive adults with generalized myasthenia gravis who responded to acute exacerbation treatment and underwent consolidation therapy
Diagnosis of myasthenia gravis (MG) based on the following:
Seropositive for anti-AChR antibodies (confirmed by reliable assay). Abnormal neuromuscular transmission on electrophysiological testing (e.g., RNS or SFEMG).
Positive neostigmine test or documented response to cholinesterase inhibitors.
Exclusion Criteria:
Initiate efgartigimod combined with standard of care (SOC) therapy according to the protocol within one month after consolidation baseline.
No additional treatments are to be administered other than the standard of care (SOC) therapy.
Proportion of patients achieving and maintaining minimal symptom expression (MSE) for at least 4 months after first attaining MSE status at any time during the consolidation therapy period within 2 months.
The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered achieving MSE if there was a 1 or 0 on the MG-ADL total score ≥4 consecutive months after first attaining MSE status at any time during the consolidation therapy period within 2 months.
Time frame: Consolidation baseline up to Month 6
Proportion of patients achieving both minimal symptom expression (MSE) and a daily corticosteroid dose ≤5 mg at Month 12.
The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered achieving MSE if there was a 1 or 0 on the MG-ADL total score.
Time frame: Consolidation baseline up to Month 12
Proportion of patients with MGFA Post-Intervention Status (MGFA-PIS) at Month 6 and Month 12
Time frame: Consolidation baseline up to Month 6 AND Month 12
Change from baseline in MG-ADL scores at Month 6 and Month 12
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity.
Time frame: Consolidation baseline up to Month 6 AND Month 12
Change from baseline in QMG scores at Month 6 and Month 12
The Quantitative Myasthenia Gravis (QMG) scale quantifies disease severity based on impairments of body functions and structures as defined by the International Classification of Disability and Health. The QMG scale consists of 13 items that measure endurance or fatigability, and accounts for fluctuations in disease state. The QMG total score range is 0-39, with higher scores indicative of greater disease severity.
Time frame: Consolidation baseline up to Month 6 AND Month 12
Proportion of patients achieving minimal symptom expression (MSE) at Month 6
Time frame: Consolidation baseline up to Month 6
Proportion of patients achieving minimal symptom expression (MSE) with daily corticosteroid dose ≤5 mg at Month 6
Time frame: Consolidation baseline up to Month 6
Incidence of acute exacerbations, impending myasthenic crisis, or myasthenic crisis events during the study period
Time frame: Consolidation baseline up to Month 12
Types and frequencies of adverse events (AEs) and serious adverse events (SAEs) during the study period
Time frame: Consolidation baseline up to Month 12
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Da, Yuwei, M.D.