Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 183
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Detailed description:

Arms:
arm 1: Double Blind Period arm 2: Double Blind Period arm 3: Open Label

Interventions: intervention 1: Abatacept intervention 2: Placebo intervention 3: Prednisone intervention 4: Abatacept
Intervention descriptions: intervention 1: Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months intervention 2: Injectable, intravenous, 0 mg, every 28 days, 12 months intervention 3: Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months intervention 4: Injectable, intravenous, 10 mg/kg, every 28 days

Protocol document: