Study of Epratuzumab in Systemic Lupus Erythematosus
An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus
2 other identifiers
interventional
29
1 country
10
Brief Summary
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2006
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
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
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 12, 2012
July 1, 2012
5.6 years
September 29, 2006
July 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
From Entry Visit 1 through end of treatment (approximately 6 years)
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)
From Entry Visit 1 through end of treatment (approximately 6 years)
Secondary Outcomes (19)
Time to treatment failure from First Visit through end of treatment (approximately 6 years)
From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)
Epratuzumab plasma concentration levels at Week 0
Week 0
Epratuzumab plasma concentration levels at Week 48
Week 48
Epratuzumab plasma concentration levels at Week 96
Week 96
Epratuzumab plasma concentration levels at Week 144
Week 144
- +14 more secondary outcomes
Study Arms (1)
Epratuzumab
EXPERIMENTALInterventions
360 mg/m\^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour
Eligibility Criteria
You may qualify if:
- Must have participated in SL0003 or SL0004 and benefitted from participation in those studies
You may not qualify if:
- Development of toxicity to epratuzumab
- Significant protocol deviations during the SL0003 or SL0004 studies
- Evidence of significant infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (10)
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
Colorado Springs, Colorado, 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
Durham, North Carolina, United States
Unknown Facility
Tulsa, Oklahoma, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 3, 2006
Study Start
June 1, 2006
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 12, 2012
Record last verified: 2012-07