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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number: 2007-002589-37 |
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The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMAB | Experimental | 1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epratuzumab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits) | 12 Week treatment cycles |
| Measure | Description | Time Frame |
|---|---|---|
| The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status | 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 |
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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 | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | 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. | |
| 26316325 | Derived | 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. |
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| Every 12 weeks |
| BILAG score assessment | Every 4 weeks through week 48, then every 12 weeks through completion |
| SLEDAI scores assessment | Every 4 weeks through week 48, then every 12 weeks through completion |
| Patient and physician VAS | 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 | Every 12 weeks |
| SF-36 PCS, MCS | Every 12 weeks |
| EQ-5D results | Every 12 weeks |
| Proportion of patients meeting treatment failure | Every 12 weeks |
| Total daily steroid dose | 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 | over the entire course of the trial |
| SLEDAI responder | 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. | over the entire course of the trial |
| Immunogenicity as measured by human anti-human antibodies | 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 | The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle |
| 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 |
| 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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