None listed
Conditions
Interventions
APPROXIMATELY 816 SLE SUBJECTS WILL BE RANDOMIZED, WITH A TARGET OF ABOUT 544 SUBJECTS RECEIVING BELIMUMAB AND 272 SUBJECTS RECEIVING PLACEBO.
IN ADDITION TO RECEIVING STABLE STANDARD THERAPY, SUBJ
10), COMPLEMENT LEVEL (C3 AND/OR C4 LOW VS OTHER), AND RACE (BLACK VS OTHER). THE FIRST DOSE OF STUDY AGENT WILL BE ADMINISTERED ON DAY O AND THEN WEEKLY (IE, EVERY 7 DAYS ± 1 DAY) THROUGH 51 WEEKS, W
Sponsors
HUMAN GENOME SCIENCES, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 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. OR • 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).
Exclusion criteria
Exclusion criteria: 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).
Countries
United States
Contacts
Public ContactYngrid Rossana Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed