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)

Not Applicable

• Registration Number: PER-059-12
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-13
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified