A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 33
- 主要终点
- Number of Participants With Partial Clinical Response (PCR)
研究概览
简要总结
This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years or above at the time of screening
- •Diagnosis of SLE
- •Active disease at screening
排除标准
- •Presence of active moderate to severe glomerulonephritis
- •Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia
- •Lack of peripheral venous access
- •Pregnancy or breast feeding mothers
- •History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin
- •Known severe chronic pulmonary disease
- •Evidence of significant or uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would impair patient participation
- •Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled) at any time in the 52 weeks prior to screening
- •Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
- •Known active infection of any kind (but excluding fungal infection of nail beds or oral thrush which has resolved before Day 1) within 30 days prior to Day
- •In addition, any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1
- •History of serious recurrent or chronic infection
- •History of cancer (except basal cell carcinoma of the skin that has been excised and cured)
- •History of alcohol or drug abuse in the 52 weeks prior to screening
- •Major surgery in the 4 weeks prior to screening excluding diagnostic surgery
- •Previous treatment with CAMPATH-1H
- •Previous treatment with a BAFF directed treatment in the 12 months prior to screening
- •Previous treatment with a B-cell targeted therapy other than one directed at BAFF
- •Treatment with any investigational agent, other than those above, in the 28 days prior to screening or five half-lives of the investigational drug (whichever is longer)
- •Receipt of any live vaccine in the 6 weeks prior to Day 1
- •Intolerance or contraindication to oral or i.v. corticosteroids
- •Treatment with a second immunosuppressive or immunomodulatory drug in the 8 weeks prior to Day 1
- •Prednisone dose of ≥ 0.7 mg/kg/day (or equivalent) for > 7 of the previous 30 days prior to screening
- •Treatment with cyclophosphamide or a calcineurin inhibitor in the 12 weeks prior to screening
- •Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but HBcAb positive may be enrolled with a negative DNA test
研究组 & 干预措施
Ocrelizumab 1000 mg
Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
干预措施: Prednisone (Drug)
Ocrelizumab 1000 mg
Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
干预措施: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) (Drug)
Ocrelizumab 1000 mg
Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
干预措施: Methylprednisolone (Drug)
Ocrelizumab 1000 mg
Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
干预措施: Ocrelizumab (Drug)
Ocrelizumab 400 mg
Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
干预措施: Prednisone (Drug)
Ocrelizumab 400 mg
Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
干预措施: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) (Drug)
Ocrelizumab 400 mg
Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
干预措施: Methylprednisolone (Drug)
Ocrelizumab 400 mg
Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
干预措施: Ocrelizumab (Drug)
Placebo
Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
干预措施: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) (Drug)
Placebo
Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Partial Clinical Response (PCR)
时间窗: Week 48
Number of Participants With Major Clinical Response (MCR)
时间窗: Week 48
Number of Non-responders (NR)
时间窗: Week 48
次要结局
- Time Adjusted Mean SLEDAI-2K Score(Week 48)
- Change in SF-36 Subscale And Summary Scores From Baseline At Week 48(Baseline, Week 48)
- Number of Participants Who Achieved a BILAG Score of C or Better at Week 24.(Week 24)
- Number of Participants Who Achieved A Major Or Partial Clinical Response At Week 48 (PCR Plus MCR Proportion), Who Did Not Experience A Flare Before Week 96(Week 48 to Week 96)
- Time to First Moderate to Severe Flare(Week 48 to Week 96)
- Annualized Flare Rate(Week 48 to Week 96)
- Number of Participants Who Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 72(Week 48 to Week 72)
- Number of Participants Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 96(Week 48 to Week 96)
- Change In FACIT-Fatigue Assessment From Baseline To Week 48(Baseline, Week 48)
- Change From Baseline In Pain Quality And Impact Of Pain On Daily Function Measured By The Brief Pain Inventory Short Form At Week 48(Baseline, Week 48)
- The EQ-5D Single Index Utility Score At Week 48(Baseline, Week 48)
- Number of Participants With Adverse Events(Up to 2.5 years)