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Study on the dose-effect relationship of rituximab in patients with myasthenia gravis and the treatment differences of different doses based on population pharmacokinetic/pharmacodynamic model

Study on the dose-effect relationship of rituximab in patients with myasthenia gravis and the treatment differences of different doses based on population pharmacokinetic/pharmacodynamic model

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058984
Enrollment
Unknown
Registered
2022-04-21
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

myasthenia gravis

Interventions

Standard dose group:Rituximab 400mg, once a week for 4 weeks
Low dose group:100mg, once a week, for 4 consecutive weeks or 100mg + 500mg single treatment

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with myasthenia gravis who have been treated with rituximab.

Exclusion criteria

Exclusion criteria: 1. Aged 80 years; 2. Patients who may have serious complications after rituximab treatment, such as infection, cardiac insufficiency, severe blood diseases, etc.; 3. Plasma replacement was used in the last 3 months; 4. Pregnant and lactating patients and patients planning to give birth during the trial; 5. Patients with malignant tumors of various systems (except thymoma); 6. The patient has a mental illness or state that does not understand the nature, scope and possible consequences of the study; 7. Drug abuse or alcoholism; 8. Patients who do not want to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters;Effective rate;Cost effectiveness ratio;

Secondary

MeasureTime frame
Concentration of rituximab;Myasthenia gravis clinical score;Percentage of lymphocytes;

Countries

China

Contacts

Public ContactChen Di

Beijing Hospital

chendiaaa111@163.com+86 13521642725

Outcome results

None listed

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