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 Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 63
- 主要终点
- Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).
详细描述
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA for at least 1 year
- •Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, etanercept or adalimumab)
- •Active RA disease of at least moderate disease activity
- •Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days
排除标准
- •Received a non-FDA approved investigational agent within the last 28 days
- •Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)
- •Currently receiving or received within the last 6 months the following: anti-CD20 antibody (rituximab) or cyclophosphamide
- •Steroid injection into any joint within the last 30 days
- •History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
- •History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days
- •Human immunodeficiency virus (HIV), Hepatitis-B, Hepatitis-C
研究组 & 干预措施
Placebo plus SOC
干预措施: Placebo (Drug)
Belimumab 1 mg/kg plus SOC
干预措施: Belimumab 1 mg/kg (Drug)
Belimumab 4 mg/kg plus SOC
干预措施: Belimumab 4 mg/kg (Drug)
Belimumab 10 mg/kg plus SOC
干预措施: Belimumab 10 mg/kg (Drug)
结局指标
主要结局
Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)
时间窗: Baseline, 24 weeks
An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]).
次要结局
- Time to First ACR50 Response, Based on ESR(0 to 24 weeks)
- Percentage of Patients With an ACR50 Response at Week 24, Based on ESR(Baseline, 24 weeks)
- Percentage of Patients With an ACR70 Response at Week 24, Based on ESR(Baseline, 24 weeks)
- Time to First ACR20 Response, Based on ESR(0 to 24 weeks)
- Time to First ACR70 Response, Based on ESR(0 to 24 weeks)
- Mean Change in Disease Activity Score 28 (DAS28) at Week 24(Baseline, 24 weeks)
- Time to First DAS28 Response(0 to 24 weeks)
- Mean Change in Modified Total Sharp Score at Week 24(Baseline, 24 weeks)