PER-007-20尚未招募未知
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must meet the following criteria for study entry:
- •Signed Informed Consent Form
- •Age 1875 years at time of signing Informed Consent Form
- •Ability to comply with the study protocol, in the investigator´s judgment
- •ISN/RPS 2003 Class III or IV LN by renal biopsy performed in the 6 months prior to screening or during screening.
- •Systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria, which are met by the presence of Class III or IV LN (above) and current or past positive antinuclear antibody (ANA).
- •UPCR 1 on a 24-hour collection at screening.
- •Receipt of at least one dose of pulse methylprednisolone IV ( 250 mg) or equivalent for treatment of the current episode of active LN during the 6 months prior to screening or during screening.
- •For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs.
- •For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm.
- •See protocol for more detail.
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo or within 6 weeks after the final dose of MMF Women of childbearing potential must have a negative urine pregnancy test at screening. Positive test results will be confirmed with a serum pregnancy test.
- •Severe renal impairment.
- •Sclerosis in 50% of glomeruli on renal biopsy
- •Presence of rapidly progressive glomerulonephritis
- •HIV infection
- •Tuberculosis (TB) infection
- •See protocol for more detail.
研究者
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