Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
NCT ID: NCT01649765
Last Updated: 2022-11-16
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
93 participants
INTERVENTIONAL
2012-09-07
2028-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
belimumab 10mg/kg IV monthly
belimumab 10mg/kg
belimumab 10mg/kg IV monthly
Arm 2
Normal Saline IV monthly
placebo
Normal Saline 250 ml
Interventions
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belimumab 10mg/kg
belimumab 10mg/kg IV monthly
placebo
Normal Saline 250 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
* Have active SLE disease (SELENA SLEDAI score ≥ 6).
* Have positive anti-nuclear antibody (ANA) test results.
* Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day 0.
* Females of childbearing age are willing to use appropriate contraception
* Subject age appropriate assent and parent or legal guardian informed consent to participate
Exclusion Criteria
* Have received treatment with belimumab (BENLYSTA®) at any time. (BENLYSTA® is a registered trademark of the GSK group of companies.)
* Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year.
* Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day 0.
* Have received high dose prednisone or equivalent (\>1.5mg/kg/day) within 60 days of baseline.
* Have received intravenous (IV) cyclophosphamide within 60 days of Day 0.
* Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline.
* Have severe lupus kidney disease.
* Have active central nervous system (CNS) lupus.
* Have had a major organ transplant.
* Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
* Have a planned surgical procedure.
* History of malignant neoplasm within the last 5 years.
* Have required management of acute or chronic infections in the past 60 days.
* Have current drug or alcohol abuse or dependence.
* Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.
* Have an IgA deficiency.
* Have severe laboratory abnormalities.
* Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
* Suicidal behavior or ideation.
* Children in Care(CiC): a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
5 Years
17 Years
ALL
No
Sponsors
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Human Genome Sciences Inc., a GSK Company
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Rosario, Santa Fe Province, Argentina
GSK Investigational Site
Capital Federal, , Argentina
GSK Investigational Site
Santa Fe, , Argentina
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Aichi, , Japan
GSK Investigational Site
Kagoshima, , Japan
GSK Investigational Site
Miyagi, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
San Luis Potosí City, , Mexico
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Tolyatti, , Russia
GSK Investigational Site
Esplugues de Llobregat. Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Bristol, , United Kingdom
GSK Investigational Site
Liverpool, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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References
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Brunner HI, Abud-Mendoza C, Viola DO, Calvo Penades I, Levy D, Anton J, Calderon JE, Chasnyk VG, Ferrandiz MA, Keltsev V, Paz Gastanaga ME, Shishov M, Boteanu AL, Henrickson M, Bass D, Clark K, Hammer A, Ji BN, Nino A, Roth DA, Struemper H, Wang ML, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial. Ann Rheum Dis. 2020 Oct;79(10):1340-1348. doi: 10.1136/annrheumdis-2020-217101. Epub 2020 Jul 22.
Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Arends EJ, Zlei M, Tipton CM, Cotic J, Osmani Z, de Bie FJ, Kamerling SWA, van Maurik A, Dimelow R, Gregan YI, Fox NL, Rabelink TJ, Roth DA, Sanz I, van Dongen JJM, van Kooten C, Teng YKO. Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2024 Sep 1;63(9):2387-2398. doi: 10.1093/rheumatology/keae286.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-000368-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
114055
Identifier Type: -
Identifier Source: org_study_id
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