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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT #: 2006-004496-36 |
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Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.
Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epratuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epratuzumab | Biological | 360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years) | From Entry Visit 1 through end of treatment (approximately 6 years) | |
| Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years) | From Entry Visit 1 through end of treatment (approximately 6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure from First Visit through end of treatment (approximately 6 years) | Treatment failure is defined as initiation of a protocol specified prohibited medication. | From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years) |
| Epratuzumab plasma concentration levels at Week 0 |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| 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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| Week 0 |
| Epratuzumab plasma concentration levels at Week 48 | Week 48 |
| Epratuzumab plasma concentration levels at Week 96 | Week 96 |
| Epratuzumab plasma concentration levels at Week 144 | Week 144 |
| Epratuzumab plasma concentration levels at Week 192 | Week 192 |
| Epratuzumab plasma concentration levels at Week 240 | Week 240 |
| Subject Epratuzumab plasma concentration levels at Week 288 | Week 288 |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 0 | Week 0 |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 48 | Week 48 |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 96 | Week 96 |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 144 | Week 144 |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 192 | Week 192 |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 240 | Week 240 |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 288 | Week 288 |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score | Baseline, Last Visit |
| Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score | Baseline, Last Visit |
| Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA) | Five point scale where 1 = very poor and 5 = very good. | Baseline, Last Visit |
| Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA) | Five point scale where 1 = very poor and 5 = very good. | Baseline, Last Visit |
| Tucson |
| Arizona |
| United States |
| Los Angeles | California | United States |
| Upland | California | United States |
| Colorado Springs | Colorado | United States |
| Denver | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Baltimore | Maryland | United States |
| Durham | North Carolina | United States |
| Tulsa | Oklahoma | United States |