Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Stopped early · Phase 2

Conditions studied: Lupus Erythematosus, Systemic

In brief

The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.

Key facts

Study ID

NCT00113971

Run by

UCB Pharma

People needed

20

Starts

2005-04-01

Expected to finish

2007-06-01

Last updated by the study team

2012-04-03

Who can join

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

You may qualify if…

• Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
• Has had SLE for at least 6 months prior to study entry
• Has at least one elevated autoantibody level at study entry
• Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)

You may not qualify if…

• Active Severe Lupus as defined by BILAG Index Level A in any body system or organ
• Allergy to human antibodies or Murine
• Prior therapy with other anti-B cell antibodies

Where it is running

• Columbia Presbyterian Medical Center — New York, New York, United States
• Lupus Center of Excellence — Pittsburgh, Pennsylvania, United States
• Rheumatology Associates — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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