A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1

CB Inc.0 个研究点目标入组 780 人开始时间: 2012年3月9日最近更新: 2015年8月4日

研究概览

暂无简介。

•- Positive antinuclear antibodies (ANA) at Screening (Visit 1)
•- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
•- Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
•- Active moderate to severe SLE disease as demonstrated by SLEDAI total score.
•- On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
•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 740
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•- Subjects who are breastfeeding, pregnant, or plan to become pregnant
•- Subjects with active, severe SLE disease activity which involves the renal system
•- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
•- Subjects with the evidence of an immunosuppressive state
•- Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
•- History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
•- Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
•- Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
•- Subjects with substance abuse or dependence or other relevant concurrent medical condition
•- Subjects with history of thromboembolic events within 1 year of screening Visit.
•- Subjects with significant hematologic abnormalities
•- Subject has received treatment with other anti- B cell antibodies within 12 months prior to randomization (Visit 2)
•- Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
•- Subject has previously received epratuzumab treatment.

发起方

CB Inc.