Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
2 other identifiers
interventional
227
11 countries
53
Brief Summary
The primary objective of the study is to assess the dose response and the dose frequency 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 Jan 2008
53 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
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedSeptember 12, 2011
July 1, 2011
1.6 years
February 15, 2008
September 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response at Week 12 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Week 12
Secondary Outcomes (28)
Response at Week 4 according to a combined response index
Week 4
Response at Week 8 according to a combined response index
Week 8
Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response
Week 4
Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response
Week 8
Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response
Week 12
- +23 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORPhosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
EMAB 600mg
EXPERIMENTAL600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.
EMAB 100mg
EXPERIMENTAL100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
EMAB 400mg
EXPERIMENTAL400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
EMAB 1200mg
EXPERIMENTAL1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
EMAB 1800mg
EXPERIMENTAL1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Interventions
Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.
Phosphate-buffered Saline (PBS) infusion.
Eligibility Criteria
You may qualify if:
- Positive ANA result at visit 1
- Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
- Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
- If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.
You may not qualify if:
- Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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 (53)
Unknown Facility
Birmingham, Alabama, United States
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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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Aventura, Florida, United States
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Tampa, Florida, United States
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Baltimore, Maryland, United States
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Brooklyn, New York, 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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Dallas, Texas, United States
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Arlington, Virginia, United States
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Milwaukee, Wisconsin, United States
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Brussels, Belgium
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Leuven, Belgium
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Curitiba, Brazil
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Goiânia, Brazil
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Porto Alegre, 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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Chai Wan, Hong Kong
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Shatin, Hong Kong
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Debrecen, Hungary
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Zalaegerszeg, Hungary
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Bangalore, India
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Hyderabad, India
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Ludhiana, India
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Madurai, 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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Valencia, Spain
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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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, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, Kilgallen B, Bongardt S, Barry A, Kelley L, Gordon C. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014 Jan;73(1):183-90. doi: 10.1136/annrheumdis-2012-202760. Epub 2013 Jan 12.
PMID: 23313811DERIVED
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 27, 2008
Study Start
January 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
September 12, 2011
Record last verified: 2011-07