The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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.
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
Time frame: 12 Week treatment cycles
The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
Time frame: 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
Time frame: Every 12 weeks
BILAG score assessment
Time frame: Every 4 weeks through week 48, then every 12 weeks through completion
SLEDAI scores assessment
Time frame: Every 4 weeks through week 48, then every 12 weeks through completion
Patient and physician VAS
Time frame: Every 4 weeks through week 48, then every 12 weeks through completion
Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline
Time frame: Every 12 weeks
SF-36 PCS, MCS
Time frame: Every 12 weeks
EQ-5D results
Time frame: Every 12 weeks
Proportion of patients meeting treatment failure
Time frame: Every 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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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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Tampa, Florida, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
...and 32 more locations
Total daily steroid dose
Time frame: Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to flare for patients who entered the study without flare as defined by the BILAG
Time frame: over the entire course of the trial
SLEDAI responder
Time frame: Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.
Time frame: over the entire course of the trial
Immunogenicity as measured by human anti-human antibodies
Time frame: at each dosing visit and 4 weeks post first dose of each treatment cycle
Assessment of changes in baseline in levels of circulating B and T cells
Time frame: The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle