| January 17, 2007 |
| September 22, 2009 |
| May 2007 |
| July 2009 (final data collection date for primary outcome measure) |
| At Wk52, the percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] |
| The primary efficacy endpoint is response rate at Week 52 |
| Complete list of historical versions of study NCT00424476 on ClinicalTrials.gov Archive Site |
- Percent of subjects with 4 points reduction from baseline in SELENA SLEDAI score at Wk 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Mean change in PGA at Wk 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Mean change in SF-36 Health Survey physical component summary score (PCS) at Wk 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Percent of subjects whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52 [ Time Frame: Weeks 40 through 52 ] [ Designated as safety issue: No ]
|
| The major secondary outscome measures include; SELENA SLEDAI; Physicians Global Assessment; quality of life; prednisone usage |
| |
| A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) |
| Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) |
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active SLE disease. |
The purpose of this SLE trial study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Systemic Lupus Erythematosus |
- Drug: belimumab
- Drug: Placebo
|
- Experimental: Belimumab 1mg/kg
- Experimental: Belimumab 10mg/kg
- Placebo Comparator: Placebo
|
| |
| |
| Completed |
| 867 |
| July 2009 |
| July 2009 (final data collection date for primary outcome measure) |
Key Inclusion Criteria:
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- On stable SLE treatment regimen.
Key Exclusion Criteria:
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received IV cyclophosphamide within 180 days of Day 0.
- Have severe lupus kidney disease.
- Have active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Hong Kong, India, Korea, Republic of, Peru, Philippines, Romania, Russian Federation, Taiwan |
| |
| NCT00424476 |
| William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc. |
| HGS1006-C1057, BLISS-52 |
| Human Genome Sciences |
| GlaxoSmithKline |
| Study Director: |
William Freimuth, MD, PhD |
Human Genome Sciences, Inc. |
|
|
| Human Genome Sciences |
| September 2009 |
