A MULTI-CENTER, RANDOMIZED PARALLEL GROUP, PLACEBO-CONTROLLEDDOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF BELIMUMAB, A HUMAN MONOCLONAL ANTI¬BLYS ANTIBODY, PLUS STANDARD THERAPY IN PEDIATRIC PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

GlaxoSmithKline,0 个研究点目标入组 0 人开始时间: 2013年5月13日最近更新: 2024年8月20日

试验速览

暂无简介。

•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:

•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)

发起方

GlaxoSmithKline,