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Sponsored by: |
La Jolla Pharmaceutical Company |
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Information provided by: | La Jolla Pharmaceutical Company |
ClinicalTrials.gov Identifier: | NCT00390091 |
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.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: abetimus sodium (LJP 394) |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
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) |
Estimated Enrollment: | 45 |
Study Start Date: | September 2006 |
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
Ages Eligible for Study: | 12 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | LJP 394-90-16 |
Study First Received: | October 17, 2006 |
Last Updated: | February 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00390091 |
Health Authority: | United States: Food and Drug Administration |
Lupus Nephritis Kidney |
SLE Systemic Lupus Erythematosus Nephritis, Lupus |
Autoimmune Diseases Lupus Erythematosus, Systemic Nephritis Connective Tissue Diseases |
Immune System Diseases |