Study of Epratuzumab in Systemic Lupus Erythematosus
A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems
2 other identifiers
interventional
N/A
13 countries
54
Brief Summary
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
54 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
September 29, 2006
CompletedFirst Posted
Study publicly available on registry
October 2, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedMay 21, 2014
March 1, 2007
September 29, 2006
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
Secondary Outcomes (4)
To continue to assess the efficacy and tolerability of epratuzumab;
To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
To continue to assess epratuzumab on Health-related quality of life in lupus patients;
To continue to assess disease status as reported by the patient and physician.
Interventions
Eligibility Criteria
You may qualify if:
- Must have completed SL0003 Alleviate A through 48 weeks
You may not qualify if:
- Development of toxicity to Epratuzumab
- Significant protocol deviations from SL0003 Study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (54)
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
Farmington, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Syracuse, 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
Gallipolis, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Arlington, Virginia, United States
Unknown Facility
Edmonds, Washington, United States
Unknown Facility
Brussels, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Rio de Janeiro, Rio de Janeiro, Brazil
Unknown Facility
Goiânia, Brazil
Unknown Facility
Rio de Janeiro, Brazil
Unknown Facility
São Paulo, Brazil
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Olomouc, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Paris, France
Unknown Facility
Toulouse, France
Unknown Facility
Erlangen, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Mannheim, Germany
Unknown Facility
München, Germany
Unknown Facility
Debrecen, Hungary
Unknown Facility
Pécs, Hungary
Unknown Facility
Ancona, Italy
Unknown Facility
Brescia, Italy
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Groningen, Netherlands
Unknown Facility
Leiden, Netherlands
Unknown Facility
Piešťany, Slovakia
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Santander, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Leeds, West Yorkshire, United Kingdom
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Newcastle upon Tyne, United Kingdom
Unknown Facility
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anna Barry
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 2, 2006
Study Start
January 1, 2007
Last Updated
May 21, 2014
Record last verified: 2007-03