An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 11
- 主要终点
- Percentage of Participants With at Least 1 Serious Adverse Event
研究概览
简要总结
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with systemic lupus erythematosus (SLE) who participated and satisfactorily completed their Week 52 evaluation in Study U2971g.
- •For partial clinical response (PCR) or nonclinical response (NCR), active disease at screening as defined by one or more domains with a British Isles Lupus Assessment Group (BILAG) A score or 2 or more domains with a BILAG B score.
排除标准
- •Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.
- •Any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety.
- •Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.
- •Subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by Week 52 in study U2971g and in whom the proposed therapy would represent risk without benefit.
- •Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
- •Pregnant women or nursing (breastfeeding) mothers.
- •History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
- •Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 8 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- •History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
- •Major surgery within 4 weeks prior to screening.
- •Intolerance or contraindication to oral or IV corticosteroids.
- •Positive hepatitis B surface antigen (BsAg) or hepatitis C serology.
- •Receipt of a live vaccine within 28 days prior to treatment.
研究组 & 干预措施
Rituximab 1000 mg
Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
干预措施: Rituximab (Drug)
Rituximab 1000 mg
Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
干预措施: Methylprednisolone (Drug)
Rituximab 1000 mg
Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
干预措施: Acetaminophen (Drug)
Rituximab 1000 mg
Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Percentage of Participants With at Least 1 Serious Adverse Event
时间窗: Baseline to the end of the study (up to 52 weeks)
A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.
次要结局
未报告次要终点