Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.
2 other identifiers
interventional
54
11 countries
60
Brief Summary
The purpose of this study is to evaluate the safety and 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 below P25 for phase_3
Started May 2005
60 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
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 29, 2006
CompletedFirst Posted
Study publicly available on registry
October 3, 2006
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
CompletedJune 7, 2012
June 1, 2012
1.8 years
September 29, 2006
June 6, 2012
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
Study Arms (2)
Epratuzumab
ACTIVE COMPARATOR360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Placebo
PLACEBO COMPARATORIntravenous
Interventions
Eligibility Criteria
You may qualify if:
- +ANA at screening
- BILAG Index B Level Activity in at least 2 body systems/organs
- Has SLE by ACR revised criteria (meets,\<4 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (60)
Unknown Facility
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Upland, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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New York, New York, United States
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Plainview, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Gallipolis, Ohio, United States
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Tulsa, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Arlington, Virginia, United States
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Edmonds, Washington, United States
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Brussels, Belgium
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Liège, Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Goiânia, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Sorocaba, Brazil
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Hradec Králové, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Paris, France
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Toulouse, France
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Erlangen, Germany
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Heidelberg, Germany
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Mannheim, Germany
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München, Germany
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Ancona, Italy
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Brescia, Italy
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Amsterdam, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Barcelona, Spain
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Madrid, Spain
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San Cristóbal de La Laguna, Spain
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Santander, Spain
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Seville, Spain
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Leeds, West Yorkshire, United Kingdom
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Birmingham, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Sheffield, United Kingdom
Unknown Facility
United Kingdom, 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
September 29, 2006
First Posted
October 3, 2006
Study Start
May 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
June 7, 2012
Record last verified: 2012-06