| October 24, 2003 |
| February 19, 2009 |
| October 2003 |
| February 2006 (final data collection date for primary outcome measure) |
| To evaluate the safety and tolerability of LymphoStat-B™ in subjects with SLE. [ Time Frame: February 2006 ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00071487 on ClinicalTrials.gov Archive Site |
| To evaluate the efficacy of LymphoStat-B™ in subjects with SLE. [ Time Frame: Februrary 2006 ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Safety and Efficacy Study of LymphoStat-B in Subjects With Systemic Lupus Erythematosus (SLE) |
| A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) |
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with active SLE disease. |
The purpose of this study is to evaluate the safety and efficacy of three different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with active SLE disease. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Lupus Erythematosus, Systemic |
- Drug: belimumab
- Drug: Placebo
|
- Experimental: 1mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
- Experimental: 4mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
- Experimental: 10mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
- Placebo Comparator: Placebo Comparator
|
- Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 Sep 15;61(9):1143-51.
- Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009 Sep 15;61(9):1168-78.
|
| |
| Completed |
| 449 |
| February 2006 |
| February 2006 (final data collection date for primary outcome measure) |
Primary Inclusion Criteria
- Clinical diagnosis of SLE
- "Active" SLE disease
- On a stable SLE treatment regimen
- History of measurable autoantibodies
Primary Exclusion Criteria
- Received a non-FDA approved investigational agent within last 28 days
- Cyclosporin, IVIG or plasmapheresis within last 90 days
- Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days
- Active CNS lupus requiring therapeutic intervention within last 60 days
- History of renal transplant
- History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
- History of hypogammaglobulinemia or IgA deficiency
- HIV, Hepatitis B, Hepatitis C
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00071487 |
| William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc. |
| LBSL02 |
| Human Genome Sciences |
|
| Study Director: |
William Freimuth, MD, PhD |
Human Genome Sciences, Inc. |
|
|
| Human Genome Sciences |
| February 2009 |
