Study of Epratuzumab in Systemic Lupus Erythematosus
A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems
2 other identifiers
interventional
510
6 countries
18
Brief Summary
The purpose of the study is to evaluate the safety \& efficacy of Epratuzumab with standard treatments for patients with SLE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2005
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2005
CompletedFirst Posted
Study publicly available on registry
May 20, 2005
CompletedStudy Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedNovember 8, 2011
November 1, 2011
1.7 years
May 19, 2005
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.
Secondary Outcomes (8)
Proportion of patients with complete response or partial response;
Individual BILAG assessments;
Physician and patient assessment scores;
Time-to treatment failure;
Successful steroid reduction by weeks 20 and 24;
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (18)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
New York, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Brussels, Belgium
Unknown Facility
Debrecen, Hungary
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Santander, Spain
Unknown Facility
Birmingham, United Kingdom
Related Publications (1)
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anna Barry
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2005
First Posted
May 20, 2005
Study Start
June 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
November 8, 2011
Record last verified: 2011-11