Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007
2 other identifiers
interventional
210
11 countries
42
Brief Summary
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2008
Typical duration for phase_2
42 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
First Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 12, 2012
July 1, 2012
3.6 years
April 15, 2008
July 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
12 Week treatment cycles
Secondary Outcomes (15)
The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
Every 4 weeks through week 48, then every 12 weeks through completion
The combined response index including an additional criteria involving the SF-36 response
Every 12 weeks
BILAG score assessment
Every 4 weeks through week 48, then every 12 weeks through completion
SLEDAI scores assessment
Every 4 weeks through week 48, then every 12 weeks through completion
Patient and physician VAS
Every 4 weeks through week 48, then every 12 weeks through completion
- +10 more secondary outcomes
Study Arms (1)
EMAB
EXPERIMENTAL1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.
Interventions
Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.
Eligibility Criteria
You may qualify if:
- SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
- Patients must have maintained eligibility requirements throughout their participation in SL0007
- Written informed consent signed prior to initiation of any study-specific assessments at visit 1
You may not qualify if:
- Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
- Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
- Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine \>2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria \>3.5gm/day
- Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
- Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (42)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Leandro, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Tampa, Florida, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Wilmington, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Arlington, Virginia, United States
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Brussels, Belgium
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Leuven, Belgium
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Goiânia, Goiás, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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Shatin, Hong Kong
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Debrecen, Hungary
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Zalaegerszeg, Hungary
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Madurai, Tamil Nadu, India
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Bangalore, India
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Hyderabad, India
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Manipal, India
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Nagpur, India
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Elblag, Poland
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Gmina Końskie, Poland
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Lublin, Poland
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Poznan, Poland
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Torun, Poland
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Barcelona, Spain
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Santander, Spain
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Donetsk, Ukraine
Unknown Facility
Ivano-Frankivsk, Ukraine
Unknown Facility
Kiev, Ukraine
Unknown Facility
Lviv, Ukraine
Unknown Facility
Birmingham, United Kingdom
Related Publications (2)
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: 33687069DERIVEDWallace DJ, Hobbs K, Clowse ME, Petri M, Strand V, Pike M, Merrill JT, Leszczynski P, Neuwelt CM, Jeka S, Houssiau F, Keiserman M, Ordi-Ros J, Bongardt S, Kilgallen B, Galateanu C, Kalunian K, Furie R, Gordon C. Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results From an Open-Label Extension Study. Arthritis Care Res (Hoboken). 2016 Apr;68(4):534-43. doi: 10.1002/acr.22694.
PMID: 26316325DERIVED
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
April 15, 2008
First Posted
April 17, 2008
Study Start
May 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 12, 2012
Record last verified: 2012-07