Pilot Trial of Belimumab in Early Lupus
This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.
• Diagnosis of SLE per current ACR classification criteria
• Date of SLE diagnosis within 2 years of screening
• ANA positive (with a titer ≥ 80)
• anti-ds DNA antibody positive
• Mild to moderate disease activity define by a SLEDAI-2K ≥4
• Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg/day.
• If on methotrexate, dose must be stable for 4 weeks
• Concomitant treatment with hydroxychloroquine unless documented inability to tolerate
• Able and willing to give written informed consent and comply with the requirements of the study protocol
• Negative serum pregnancy test (for women of child bearing potential)
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 16 weeks after completion of treatment