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20日最近更新: 2016年1月18日

适应症

试验速览

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: 0
•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 screening (visit 1) - 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.