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Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

NCT01639339

CompletedPhase 3

Sponsor: Human Genome Sciences Inc., a GSK Company

Conditions: Lupus Nephritis

Interventions: Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy

Countries: United States, Argentina, Belgium, Brazil, Canada, China, Colombia, Czechia

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
* Biopsy confirmed active lupus nephritis.
* Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.
* Autoantibody-positive.

Key Exclusion Criteria:

* Pregnant or nursing.
* On dialysis within the past year.
* Treatment with belimumab within the past year .
* Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study.
* Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
* Severe active central nervous system (CNS) lupus.
* Required management of acute or chronic infections within the past 60 days.
* Current drug or alcohol abuse or dependence.
* Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of severe allergic reaction to contrast agents or biological medicines.
Locations (118)
  • La Palma, California, United States
  • San Leandro, California, United States
  • Torrance, California, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • St Louis, Missouri, United States
  • Brooklyn, New York, United States
  • Great Neck, New York, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Columbus, Ohio, United States
  • Bethlehem, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Onalaska, Wisconsin, United States
  • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Córdoba, Argentina
  • Mendoza, Argentina
  • Brussels, Belgium
  • Brussels, Belgium
  • Leuven, Belgium
  • Belo Horizonte, Minas Gerais, Brazil
  • Juiz de Fora, Minas Gerais, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São José do Rio Preto, São Paulo, Brazil
  • + 88 more on CT.gov