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Study on the Safety and Efficacy of Eculizumab in Different Subgroups of Adults with Refractory Myasthenia Gravis

Study on the Safety and Efficacy of Eculizumab in Different Subgroups of Adults with Refractory Myasthenia Gravis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098555
Enrollment
Unknown
Registered
2025-03-10
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis

Interventions

Thymoma combined with MG group:None
Non-thymoma MG group:None

Sponsors

Shijiazhuang People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-70 years, no gender restrictions; 2. Diagnosed with generalized Myasthenia Gravis (gMG) with a documented diagnosis and at least one of the following supporting evidence: a. History of neuromuscular transmission abnormalities confirmed by single-fiber electromyography or repetitive nerve stimulation; b. Positive response to neostigmine test. 3.Positive serological test for AchR antibodies; 4.Patients classified as MGFA clinical types II to V; 5. Refractory myasthenia gravis patients who show no improvement or worsening of the condition despite adequate doses and courses of corticosteroids or at least two immunosuppressants; refractory myasthenia gravis patients whose symptoms cannot be controlled by adequate doses of IVIG, PLE, or FcRN inhibitors; refractory myasthenia gravis patients with significant adverse drug reactions; 6.Subjects voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Presence of psychiatric disorders or family history of such disorders; 2.History of malignancies other than thymoma, with evidence of recurrence within <=3 years; 3.Received IVIG or PLEX treatment within the past month, rituximab treatment within the past 6 months, eculizumab treatment within the past 2 months, or ravulizumab or other complement inhibitors within the past 3 months; 4.Presence of clinically significant active or chronic uncontrolled infections at the time of screening: history of recurrent invasive infections caused by encapsulated organisms (e.g., Neisseria meningitidis and Streptococcus pneumoniae); active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection; 5.Pregnant or breastfeeding patients, or those planning to become pregnant; 6. Any condition that the researcher believes may prevent the subject from completing the study or pose significant risk to the subject.

Design outcomes

Primary

MeasureTime frame
ADL response rate in thymoma combined with MG and non-thymoma MG;QMG response rate in thymoma combined with MG and non-thymoma MG;

Secondary

MeasureTime frame
Prednisone reached a response rate of =5mg/ day;Serum AChR-ab difference;

Countries

China

Contacts

Public ContactQi Guoyan

Shijiazhuang People’s Hospital

qiguoyan1106@sina.com+86 176 0311 9295

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026