The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 \[NCT01449071\] phase I/II trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Epratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48, 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87)
10
Fukuoka, Japan
11
Fukuoka, Japan
9
Fukuoka, Japan
3
Kitakyushu, Japan
1
Tokyo, Japan
Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)
Time frame: up to Week 100
Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96
Time frame: From Baseline (Week 0) to Week 96
Epratuzumab plasma concentration at Week 96
Time frame: Week 96
Number of subjects reporting anti-Epratuzumab in plasma at Week 96
Time frame: Week 96
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8
Tokyo, Japan