GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 709
- 试验地点
- 1
- 主要终点
- Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.
详细描述
The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older.
- •Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
- •Have active SLE disease.
- •Have positive anti-nuclear antibody (ANA) test results.
- •Are on a stable SLE treatment regimen.
- •Females of childbearing age are willing to use appropriate contraception
排除标准
- •Have received treatment with any B cell targeted therapy at any time.
- •Have received a biologic investigational agent in the past year.
- •Have received 3 or more courses of systemic corticosteroids in the past year.
- •Have received intravenous (IV) cyclophosphamide within 180 days prior to Day
- •Have severe lupus kidney disease.
- •Have active central nervous system (CNS) lupus.
- •Have had a major organ transplant.
- •Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
- •Have a planned surgical procedure.
- •Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix.
- •Have required management of acute or chronic infections in 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.
- •Have an IgA deficiency.
- •Have severe laboratory Abnormalities.
- •Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
- •Suicidal behavior or ideation.
研究组 & 干预措施
Belimumab
10mg/kg
干预措施: Belimumab (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
时间窗: Week 52
SRI response is a composite index, defined as the percent of participants with \>=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of \< 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
次要结局
- Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.(52 weeks)
- Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.(Week 52)
- Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase(Weeks 24 and 48 for Years 2, 3, 4, 5 and 6)
- Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.(Baseline (Day 0) and Week 52)
- Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.(Baseline (Day 0) and Week 52)