Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease

Completed · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.

Key facts

Study ID

NCT00660881

Run by

UCB Pharma

People needed

210

Starts

2008-05-01

Expected to finish

2011-12-01

Last updated by the study team

2012-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
• Patients must have maintained eligibility requirements throughout their participation in SL0007
• Written informed consent signed prior to initiation of any study-specific assessments at visit 1

You may not qualify if…

• Patients may not receive 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Leandro, California, United States
• Study site — Denver, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Arlington, Virginia, United States
• Study site — Brussels, Belgium
• Study site — Leuven, Belgium
• Study site — Goiânia, Goiás, Brazil
• Study site — Porto Alegre, Brazil
• Study site — São Paulo, Brazil
• Study site — Shatin, Hong Kong
• Study site — Debrecen, Hungary
• Study site — Zalaegerszeg, Hungary
• Study site — Madurai, Tamil Nadu, India
• Study site — Bangalore, India
• Study site — Hyderabad, India

Full record on ClinicalTrials.gov

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