Trial Information

Summary: Study of Epratuzumab in Serologically-Positive Systemic Lupus Erythematosus Patients With Active Disease

A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Dose and Dose Regimen-Ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-Positive Systemic Lupus Erythematosus Patients With Active Disease

Inclusion Criteria:

• Positive ANA result at visit 1 either via screening or confirmatory laboratory testing methodologies;
• Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met;
• Active moderate or severe SLE disease activity as demonstrated by BILAG A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present; if on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.

Exclusion Criteria:

• Patients receiving any live vaccination within 2 weeks prior to visit 1 or during the course of the study; Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures; Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day;
• Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment. Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.

Contact: UCB Clinical Trial Call Center Located in: Dallas, TX Telephone: 1-877-822-9493

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Trial listings updated: June 1, 2008 at 6:44:43 AM