PER-046-12未知未知
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BELIMUMAB (HGS 1006) ADMINISTERED SUBCUTANEOUSLY (SC) TO SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE).
试验速览
- 阶段
- 未知
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. ARE AT LEAST 18 YEARS OF AGE.
- •2. HAVE A CLINICAL DIAGNOSIS OFSLE ACCORDING TO THE AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CRITERIA. (APPENDIX 1).
- •3. HAVE ACTIVE SLE DISEASE DEFINED AS A SELENA SLEDAI SCORE ≥ 8 AT SCREENING. (APPENDIX 3). (REFER TO SECTION 6.9.1.1 SCORING FOR PROTEINURIA FOR ELIGIBILITY AND AT SCREENING.)
- •4. HAVE UNEQUIVOCALLY POSITIVE AUTOANTIBODY TEST RESULTS DEFINED AS AN ANA TITRE ≥ 1:80 AND/OR A POSITIVE ANTI-DSDNA (≥ 30 IU/ML) SERUM ANTIBODY TEST FROM 2 INDEPENDENT TIME POINTS AS FOLLOWS:
- •POSITIVE TEST RESULTS FROM 2 INDEPENDENT TIME POINTS WITHIN THE STUDY SCREENING PERIOD. SCREENING RESULTS MUST BE BASED ON THE STUDY´S CENTRAL LABORATORY RESULTS.
- •ONE POSITIVE HISTORICAL TEST RESULT AND 1 POSITIVE TEST RESULT DURING THE SCREENING PERIOD.
- •- HISTORICAL DOCUMENTATION OF A POSITIVE TEST OF ANA (EG, ANA BY HEP-2 TITER)
- •OR ANTI-DSDNA (EG, ANTI-DSDNA BY FARR ASSAY) MUST INCLUDE THE DATE AND TYPE OF THE TEST, THE NAME OFTHE TESTING LABORATORY, NUMERICAL REFERENCE RANGE, AND A KEY THAT EXPLAINS VALUES PROVIDED AS POSITIVE VS NEGATIVE OR NEGATIVE.
- •EQUIVOCAL/BORDERLINE POSITIVE).
排除标准
- •1. HAVE RECEIVED TREATMENT WITH ANY B CELL TARGETED THERAPY (EG, RITUXIMAB, OTHER ANTI-CD20 AGENTS, ANTI-CD22 [EPRATUZUMAB], ANTI-CD52 [ALEMTUZUMAB], BLYS-RECEPTOR FUSION PROTEIN [BR3], TACI-FC, ANTI-BAFF (LY2127399) OR ANTI-BLYS [BELIMUMAB]) AT ANY TIME.
- •2. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 364 DAYS OF DAY O:
- •ABATACEPT.
- •A BIOLOGIC INVESTIGATIONAL AGENT OTHER THAN B CELL TARGETED THERAPY (EG, ABETIMUS SODIUM, ANTI-CD40L ANTIBODY [BG9588/ IDEC-131 D. (INVESTIGATIONAL AGENT APPLIES TO ANYDRUG NOT APPROVED FOR SALE IN THE COUNTRY IN WHICH IT IS BEING USED.)
- •3. HAVE REQUIRED 3 OR MORE COURSES OF SYSTEMIC CORTICOSTEROIDS FOR CONCOMITANT CONDITIONS (EG, ASTHMA, ATOPIC DERMATITIS) WITHIN 364 DAYS OFDAY O. (TOPICAL OR INHALED STEROIDS ARE PERMITTED. )
- •4. HAVE RECEIVED ANY OFTHE FOLLOWING WITHIN 90 DAYS OFDAY O:
- •ANTI-TNF THERAPY (EG, ADALIMUMAB, ETANERCEPT, INFLIXIMAB).
- •INTRAVENOUS (IV) CYCLOPHOSPHAMIDE.
- •INTERLEUKIN-L RECEPTOR ANTAGONIST (ANAKINRA).
- •INTRAVENOUS IRNRNUNOGLOBULIN (LVIG).
- •HIGH DOSE PREDNISONE OR EQUIVALENT (> 100 RNG/DAY).
- •PLASMAPHERESIS.
- •5. RAVE RECEIVED ANY OFTHE FOLLOWING WITHIN 60 DAYS OF DAY 0:
- •A NON-BIOLOGIC INVESTIGATIONAL AGENT.
- •ANY NEW IMMUNOSUPPRESSIVE/IMMUNOMODULATORY AGENT, ANTI-MALARIAL, OR NSAID (SEE INCLUSION CRITERION #5).
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