Study of LJP 394 (Abetimus Sodium) in Lupus Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
|Official Title:||A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)|
- 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.
|Study Start Date:||September 2006|
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390091
|United States, California|
|Wallace Rheumatic Study Center|
|Los Angeles, California, United States, 90048|
|United States, Pennsylvania|
|Altoona Center for Clinical Research|
|Duncansville, Pennsylvania, United States, 16635|
|Study Chair:||Matthew D Linnik, PhD||La Jolla Pharmaceutical Company|