Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
NCT ID: NCT00624351
Last Updated: 2011-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
227 participants
INTERVENTIONAL
2008-01-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
Placebo
Phosphate-buffered Saline (PBS) infusion.
EMAB 600mg
600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.
Epratuzumab
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.
EMAB 100mg
100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Epratuzumab
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.
Placebo
Phosphate-buffered Saline (PBS) infusion.
EMAB 400mg
400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Epratuzumab
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.
Placebo
Phosphate-buffered Saline (PBS) infusion.
EMAB 1200mg
1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Epratuzumab
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.
Placebo
Phosphate-buffered Saline (PBS) infusion.
EMAB 1800mg
1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Epratuzumab
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.
Placebo
Phosphate-buffered Saline (PBS) infusion.
Interventions
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Epratuzumab
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.
Placebo
Phosphate-buffered Saline (PBS) infusion.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
San Leandro, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Aventura, Florida, United States
Tampa, Florida, United States
Baltimore, Maryland, United States
Brooklyn, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Wilmington, North Carolina, United States
Oklahoma City, Oklahoma, United States
Dallas, Texas, United States
Arlington, Virginia, United States
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Leuven, , Belgium
Curitiba, , Brazil
Goiânia, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Chai Wan, , Hong Kong
Shatin, , Hong Kong
Debrecen, , Hungary
Zalaegerszeg, , Hungary
Bangalore, , India
Hyderabad, , India
Ludhiana, , India
Madurai, , India
Manipal, , India
Nagpur, , India
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Elblag, , Poland
Gmina Końskie, , Poland
Lublin, , Poland
Poznan, , Poland
Torun, , Poland
Barcelona, , Spain
Santander, , Spain
Valencia, , Spain
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Birmingham, , United Kingdom
Countries
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References
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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.
Wallace 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.
Other Identifiers
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2007-002566-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SL0007
Identifier Type: -
Identifier Source: org_study_id
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