Status:
WITHDRAWN
Study of LJP 394 (Abetimus Sodium) in Lupus Patients
Lead Sponsor:
La Jolla Pharmaceutical Company
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
12-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00390091
Start Date
September 1 2006
Last Update
September 1 2015
Active Locations (2)
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1
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
2
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635