Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Epratuzumab

Criteria

Inclusion Criteria:

• 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.)

Exclusion criteria:

• 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