EUCTR2005-000705-59-SK进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 510
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Male or female, 18 years and older;
- •-Signed written informed consent obtained prior to study entry;
- •-Has SLE by American College of Rheumatology revised criteria (meets at least 4 criteria);
- •-Has had SLE for at least 6 months prior to study entry;
- •-Has at least one elevated lupus-associated autoantibody level at or any time prior to study entry;
- •-Has new onset of BILAG index A level activity in at least one body/organ system outside the renal and neurologic systems which developed within 4 weeks of study entry;
- •-If initiated corticosteroids >20 mg/day prednisone (or equivalent) for treatment of the current flare, within 14 days of anticipated first infusion of study drug;
- •-If on immunosuppresives, receiving a stable regimen for at least 8 weeks prior to study entry; and
- •-If on antimalarials, receiving a stable regimenfor at least 12 weeks prior to study entry.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test;
- •-Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control during and for a period of 6 months after the completion of the study;
- •-Active severe CNS disease;
- •-Active severe renal disease;
- •-Treatment with Lymphostat B, or CTLA4-Ig within 6 months, or with rituximab or other anti-B-cell ABs within 12 months;
- •-Allergy to murine or human ABs;
- •-Experimental therapy or any therapy with human or murine ABs within 3 months;
- •Cyclophosphamide, cyclosporin, intravenous, joint or IM injections of corticosteroids exceeding 120 mg methylprednisolone, 60 mg triamcinolone, or equivalent; IV immunoglobulins, or any IMPs within 4 weeks;
- •-Thrombosis, spontaneous or induced abortion, stillbirth or live birth, within 4 weeks;
- •-Patients with antiphospholipid ABs AND a history of thromboembolic events;
- •-On oral anticoagulants within 4 weeks;
- •-History of malignancy (except basal or squamous cell carcinoma, cervical CIS);
- •-Active infection receiving antibiotics within 7 days of screening or infection requiring hospitalization or herpes zoster treatment within 4 weeks; long-term infectious diseases (tuberculosis, fungal infections) active within 2 years;
- •-Known HIV, hepatitis B or C infection, or other immunosuppressive states;
- •-Live vaccine within 4 weeks;
- •-Hematological abnormalities not attributed to lupus;
- •-Liver transaminases or alkaline phosphatase > 3X upper limit of normal and not attributed to SLE;
- •-Serum creatinine > 2.5 mg/dL or clinically significant increases within 4 weeks, or proteinuria > 3.5 mg/day; and
- •-Sustance abuse or other concurrent medical conditions that, in the investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
研究者
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