Assessment of concentrations of belimumab in body fluids of patients with systemic lupus erythematosus

Assessment of concentrations of belimumab in body fluids of patients with systemic lupus erythematosus - Concentrations of belimumab in SLE patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49577

Enrollment

Registered

2020-06-17

Start date

2020-07-27

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

lupus systemische lupus erythematosus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis with SLE according to the American College of Rheumatology (ACR) revised criteria for the classification of SLE - Age 18 years or older - Current treatment with belimumab (intravenous or subcutaneous administration) - Signed informed consent form

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Our main endpoint is the concentration of belimumab in seminal fluid in men with SLE, treated with (intravenous and subcutaneous) belimumab.	—

Secondary

Measure	Time frame
Our secondary endpoints are: - the concentration of belimumab in blood in male and female patients with SLE, treated with belimumab (intravenously or subcutaneously); - the seminal fluid : blood concentration ratio of belimumab in male patients with SLE treated with belimumab (intravenously or subcutaneously); - the concentration of belimumab in saliva in male and female patients with SLE, treated with belimumab (intravenously or subcutaneously).	—

Measure

Time frame

Our secondary endpoints are: - the concentration of belimumab in blood in male and female patients with SLE, treated with belimumab (intravenously or subcutaneously); - the seminal fluid : blood concentration ratio of belimumab in male patients with SLE treated with belimumab (intravenously or subcutaneously); - the concentration of belimumab in saliva in male and female patients with SLE, treated with belimumab (intravenously or subcutaneously).

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Countries

Netherlands

Outcome results