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A Study on the Efficacy and Safety of Telitacicept for Injection in the Treatment of Generalized Myasthenia Gravis with Positive Anti-Acetylcholine Receptor Antibodies

A Study on the Efficacy and Safety of Telitacicept for Injection in the Treatment of Generalized Myasthenia Gravis with Positive Anti-Acetylcholine Receptor Antibodies

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109279
Enrollment
Unknown
Registered
2025-09-16
Start date
2025-09-16
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Myasthenia gravis

Interventions

Control group:None

Sponsors

The First Affiliated Hospital of China Medical University, Shenyang, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients voluntarily signed the informed consent form. 2) Diagnosed with generalized myasthenia gravis (gMG) according to the 2020 Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis, meeting the following criteria: Muscle weakness involves ocular, pharyngeal, limb, facial, masticatory, and neck muscles, characterized by fluctuating and fatigable symptoms (i.e., symptoms are milder in the morning and worsen in the evening, exacerbate with sustained activity, and improve with rest). Diagnosis can be established by meeting any two of the following three criteria: a. Positive neostigmine test (quantitative assessment using the Xu's scale) or symptom improvement after oral pyridostigmine bromide; b. Electromyography (EMG) findings: repetitive nerve stimulation (RNS) shows a decremental response of >10% in low-frequency stimulation in at least one nerve, or single-fiber electromyography (SFEMG) reveals increased "jitter" in two or more muscles; c. Serological testing positive for AChR-Ab. 3) Age between 18 and 80 years. 4) Treated with either Telitacicept or conventional immunosuppressants, including glucocorticoids and/or tacrolimus. 5) Completed a follow-up observation period of 12 months.

Exclusion criteria

Exclusion criteria: 1) Ocular myasthenia gravis or myasthenic crisis. 2) Pregnancy or lactation. 3) Any ongoing bacterial or viral infection not treated with antibiotics or antiviral therapy. 4) Use of other targeted therapies or immunosuppressants besides Telitacicept, glucocorticoids, or tacrolimus. 5) Incomplete medical records or loss to follow-up.

Countries

China

Contacts

Public ContactRuixia Zhu

The First Affiliated Hospital of China Medical University, Shenyang, China

zrx_200626313@163.com+86 135 0403 5936

Outcome results

None listed

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