Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.


Options:
A: Primary Inclusion Criteria

1. Have completed the LBSL02 trial and achieved a satisfactory response.

Primary Exclusion Criteria

1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
3. Used any of the following prohibited medications during their participation in LBSL02:

   * Other investigational agents.
   * Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
   * Intravenous cyclophosphamide.
   * Corticosteroids \>100 mg/day prednisone equivalent for reasons other than severe SLE flare.
B: Key Inclusion Criteria:

* Clinical diagnosis of SLE by ACR criteria
* Stable SLE disease activity
* On stable SLE treatment regimen
* History of measurable autoantibodies

Key Exclusion Criteria:

* Pregnant or nursing
* Received a non-FDA approved investigational agent within last 28 days
* Received cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 6 months
* Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 6 months
* Active central nervous system (CNS) lupus requiring medical intervention within last 6 months
* History of renal transplant
* History of clinical evidence of an active significant acute or chronic diseases
* Have required management or hospitalization of any infection within last 4 weeks.
* History of hypogammaglobulinemia or IgA deficiency
* Have current drug or alcohol addiction
* History of or test positive at screening for HIV, Hepatitis B or Hepatitis C
C: Key Inclusion Criteria:

* Clinical diagnosis of SLE by ACR criteria.
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen.

Key Exclusion Criteria:

* Pregnant or nursing
* Have received treatment with any B cell targeted therapy.
* Have received treatment with a biological investigational agent in the past year.
* Have received IV cyclophosphamide within 180 days of Day 0.
* Have severe lupus kidney disease.
* Have active central nervous system (CNS) lupus.
* Have required management of acute or chronic infections within 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.
D: Inclusion Criteria:

* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
* Active SLE disease
* On stable SLE treatment regimen

Exclusion Criteria:

* Pregnant or nursing
* Have received treatment with an B cell targeted therapy
* Have received treatment with a biologic investigational agent in the past year
* Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
* Have severe lupus kidney disease
* Have active central nervous system (CNS) lupus
* Have required management of acute or chronic infections with the past 60 days
* Have current drug or alcohol abuse or dependence or within the past year
* Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention

Answer: D