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A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

NCT00583362

CompletedPhase 2

Sponsor: Human Genome Sciences Inc., a GSK Company

Conditions: Systemic Lupus Erythematosus

Interventions: Belimumab

Countries: United States, Canada

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (57)
  • Birmingham, Alabama, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • San Jose, California, United States
  • Upland, California, United States
  • Colorado Springs, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Aventura, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Boise, Idaho, United States
  • Idaho Falls, Idaho, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Munster, Indiana, United States
  • Kansas City, Kansas, United States
  • Louisville, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Cumberland, Maryland, United States
  • Wheaton, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • + 27 more on CT.gov