Status:
TERMINATED
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
UCB Pharma
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00113971
Start Date
April 1 2005
End Date
June 1 2007
Last Update
April 3 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
2
Lupus Center of Excellence
Pittsburgh, Pennsylvania, United States, 15261
3
Rheumatology Associates
Charleston, South Carolina, United States, 29407