Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
NCT ID: NCT00660881
Last Updated: 2012-07-12
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
210 participants
INTERVENTIONAL
2008-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EMAB
1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.
Epratuzumab
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.
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 PBS as a vehicle/buffer for the infusion procedure.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
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
Tampa, Florida, 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
Arlington, Virginia, United States
Brussels, , Belgium
Leuven, , Belgium
Goiânia, Goiás, Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
Shatin, , Hong Kong
Debrecen, , Hungary
Zalaegerszeg, , Hungary
Madurai, Tamil Nadu, India
Bangalore, , India
Hyderabad, , 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
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, 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.
Other Identifiers
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EudraCT Number: 2007-002589-37
Identifier Type: -
Identifier Source: secondary_id
SL0008
Identifier Type: -
Identifier Source: org_study_id