Trial Information

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Investigational Product in Patients With Systemic Lupus Erythematosus (SLE)

Patient Inclusion Criteria:

Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
Have positive antinuclear antibodies (ANA)
Agree not to become pregnant throughout the course of the trial
Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening

Patient Exclusion Criteria

Have active severe Lupus kidney disease
Have active Central Nervous System or peripheral neurologic disease
Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
Have active or recent infection within 30 days of screening
Have had a serious infection within 90 days of randomization
Have evidence or test positive for Hepatitis B
Have Hepatitis C
Are human immunodeficiency virus (HIV) positive
Have evidence of active or latent tuberculosis (TB)
Presence of significant laboratory abnormalities at screening
Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
Have changed your dose of antimalarial drug in the past 30 days
Have changed your dose of immunosuppressive drug in the past 90 days
Have previously received rituximab

Suzi DeFiesta, Research Administrator
CSI Research Inc
11379 Southbridge Parkway Suite B
Alpharetta, GA 30022
Phone: 770-667-0220
Fax: 770-667-0227
Email: sdefiesta@csi-research.com

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Research Center Information: CSI Research Inc

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