None listed
Conditions
Interventions
None listed
Sponsors
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ARE 5 TO 17 YEARS OF AGE 2. HAVE OR HAVE HAD IN SERIES, 4 OR MORE OF THE AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) 11 CRITERIA FOR THE CLASSIFICATION OF SLE 3. HAVE ACTIVE SLE DISEASE DEFINED AS A SELENA SLEDAI SCORE = 8 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:
Exclusion criteria
Exclusion criteria: 1. HAVE RECEIVED TREATMENT WITH ANY B-CELL TARGETED THERAPY (E.G., RITUXIMAB, OTHER ANTI¬CD20 AGENTS, ANTI-CD22 [EPRATUZUMAB], ANTI-CD52 [ALEMTUZUMAB], BLYS-RECEPTOR FUSION PROTEIN [BR3], TACI-FC, OR BELIMUMAB) AT ANY TIME. 2. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 364 DAYS OF DAY 0: . ABATACEPT. . A BIOLOGIC INVESTIGATIONAL AGENT 3. HAVE REQUIRED 3 OR MORE COURSES OF SYSTEMIC CORTICOSTEROIDS FOR CONCOMITANT CONDITIONS (E.G., ASTHMA, ATOPIC DERMATITIS) WITHIN 364 DAYS OF DAY 0 (TOPICAL OR INHALED STEROIDS ARE PERMITTED). 4. HAVE RECEIVED INTRAVENOUS (TV) CYCLOPHOSPHAMIDE WITHIN 90 DAYS OF DAY O. 5. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 90 DAYS OF DAY 0: . ANTI-TNF THERAPY (E.G., ADALIMUMAB, ETANERCEPT, INFLIXIMAB). . INTERLEUKIN-1 RECEPTOR ANTAGONIST (ANAKINRA). . INTRAVENOUS IMMUNOGLOBULIN (IVIG). . HIGH DOSE PREDNISONE (> 1.5 MG/KG/DAY) OR EQUIVALENT. . PLASMAPHERESIS. 6. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 60 DAYS OF DAY 0: . A NON-BIOLOGIC INVESTIGATIONAL AGENT. . ANY NEW IMMUNOSUPPRESSIVE/IMMUN.OMODULATORY AGENT, ANTI-MALARIAL, NSAID, (SEE INCLUSION CRITERIA #5)
Countries
Japan, Korea North
Outcome results
None listed