Belimumab

A Phase 3, multi-center, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of Belimumab (HGS1006) administered sucutaneously (SC) to subjects with systemic lupus erythematosus (SLE)

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  1. At least 18 years of age.
  2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
  3. SLEDAI >8
  4. Autoantibody-positive.
  5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

  1. Pregnant or nursing.
  2. Have received treatment with a B cell targeted therapy (for example, rituximab) within the past year.
  3. Have received treatment with an investigational biological agent in the past year.
  4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
  5. Have severe active lupus kidney disease.
  6. Have severe active central nervous system (CNS) lupus.
  7. Have required management of acute or chronic infections within the past 60 days.
  8. Have current drug or alcohol abuse or dependence.
  9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.