NCT00752999撤回2 期
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months.
研究概览
简要总结
Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.
详细描述
This study is a multi-center, multinational, randomized, double-blind, placebo-controlled Phase II clinical trial. Study enrollment will comprise approximately 225 patients meeting study inclusion requirements. The study will be conducted at up to 80 multinational investigational sites. Eligible patients will be randomized (2:1) into one of two 6 month treatment groups. One group (approximately 150 patients) will receive R788 150 mg PO bid; the other treatment group (approximately 75 patients) will receive placebo.
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
- •Patients must give written informed consent to participate in this study by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
- •Males and females, 18 years of age or older, with active SLE diagnosed at least 6 months prior to Day 1 dosing. Active SLE is defined as having fulfilled the ACR criteria for SLE.
- •Patients of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use an effective method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent).
- •The patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period.
- •In the investigator's opinion, the patient has the ability to understand the nature of the study and any anticipated risks of participation, communicate satisfactorily with the investigator, and participate in and comply with the requirements of the entire protocol.
排除标准
- •The patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
- •Clinically significant or uncontrolled medical disease in any organ system, other than due to SLE.
- •Background immunosuppressive therapy that has not remained stable ≤ 4 weeks prior to baseline.
- •Severe active or unstable renal disease.
- •Active severe neuropsychiatric SLE.
- •Female patients must not be breastfeeding and must have a negative urine pregnancy test per the Schedule of Study Activities.
- •The patient has a history of substance abuse, drug addiction, or alcoholism.
研究组 & 干预措施
A
Experimental
150 mg tablet, oral, twice-a-day
干预措施: Fostamatinib Disodium (R935788) (Drug)
B
Placebo Comparator
Placebo tablet, oral, twice-a-day
干预措施: Placebo (Drug)
结局指标
主要结局
The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months.
时间窗: 6 months
次要结局
- Composite Responder analysis defined as ≥4 points improvement in SELENA-SLEDAI and no 'Severe SLE flare' after Week 6. No worsening (≤10 mm on VAS) of Physician Global Assessment, or, no worsening of SF 36 PCS (not >-0.8) or PFI (not >2.5)(3 and 6 months)
- Attainment of daily prednisone dose decrease in those patients on daily corticosteroids by 50% or to ≤ 7.5 mg prednisone (or equivalent for other corticosteroids) at 3 and 6 months.(3 and 6 months)
- Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.(At each post baseline visit)
- Attainment of improvement in SELENA-SLEDAI by ≥ 2 points at Weeks 2 and 4.(Weeks 2 and 4)
- Attainment of improvement in SELENA-SLEDAI by ≥ 4 points at each post baseline visit.(At each post baseline visit)
- Change from baseline of Physician Global Assessment by VAS over 6 months.(6 months)
- Time to rescue medication.(At each post baseline visit)
- Time to severe SLE flare by SELENA Flare Index.(At each post baseline visit)
- Change from baseline in the component scores of the SF 36 at Month 3 and Month 6.(Month 3 and 6)
- Effects on liver function tests, clinically significant reductions in peripheral neutrophil counts, G-I adverse effects, new onset or aggravated hypertension, and other adverse effects as they may appear.(At each post baseline visit)
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