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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epratuzumab 4x600 mg every 12 weeks Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epratuzumab | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks) | up to Week 100 | |
| Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96 | From Baseline (Week 0) to Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96 | 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 | From Baseline (Week 0) to Week 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 10 | Fukuoka | Japan | ||||
| 11 |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C448700 | epratuzumab |
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| Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96 | From Baseline (Week 0) to Week 96 |
| Epratuzumab plasma concentration at Week 96 | Week 96 |
| Number of subjects reporting anti-Epratuzumab in plasma at Week 96 | Week 96 |
| Fukuoka |
| Japan |
| 9 | Fukuoka | Japan |
| 3 | Kitakyushu | Japan |
| 1 | Tokyo | Japan |
| 8 | Tokyo | Japan |