Status:
TERMINATED
Study of Epratuzumab in Systemic Lupus Erythematosus
Lead Sponsor:
UCB Pharma
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the safety \& efficacy of Epratuzumab with standard treatments for patients with SLE.
Eligibility Criteria
Inclusion
- Has SLE by ACR revised criteria (meets \<4 criteria);
- Has SLE with at least one elevated lupus antibody;
- Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic
Exclusion
- Active severe CNS or Renal disease defined by BILAG as Level A
- Allergy to murine or human antibodies
- Antiphospholid antibodies AND a history of thrombocytopenic events
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00111306
Start Date
June 1 2005
End Date
March 1 2007
Last Update
November 8 2011
Active Locations (18)
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1
Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
Los Angeles, California, United States
4
Upland, California, United States