Conditions: Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease
Keywords: Lupus SLE Systemic Lupus Erythematosis autoimmune disease LY2127399 Immune system disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1164
Healthy volunteers: no

Brief summary:
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.

Detailed description:

Arms:
arm 1: Administered SC arm 2: During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. arm 3: Administered SC

Interventions: intervention 1: LY2127399 intervention 2: Placebo every 2 weeks intervention 3: Placebo every 4 weeks intervention 4: Standard of Care
Intervention descriptions: intervention 1: 120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. intervention 2: Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose intervention 3: Administered via subcutaneous injection for 52 weeks. intervention 4: None

Protocol document: