Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus
Brief summary
The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.
Detailed description
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
Interventions
Sponsors
La Jolla Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males or females between 12 and 70 years old. * Diagnosis of Systemic Lupus Erythematosus (SLE) * Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study. * Ability to have weekly intravenous (IV) administration of study drug.
Exclusion criteria
* Prior exposure to abetimus sodium within 6 months prior to screening. * Patients not on stable medications for 30 days prior to screening. * Patients with acute or chronic infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment of the safety and pharmacodynamic effect of abetimus sodium at | — |
| doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in | — |
| patients with SLE will be based on laboratory data from the central laboratory | — |
| and confirmed by supporting data. The pharmacodynamic effic will be assessed | — |
| using historical placebo effect as a control. | — |
Countries
United States
Outcome results
None listed