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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002566-35 | EudraCT Number |
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The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3. |
|
| EMAB 600mg | Experimental | 600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3. |
|
| EMAB 100mg | Experimental | 100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
|
| EMAB 400mg | Experimental | 400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
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| EMAB 1200mg | Experimental | 1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
|
| EMAB 1800mg | Experimental |
| 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 Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Response at Week 12 according to a combined response index | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Response at Week 4 according to a combined response index | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status. | Week 4 |
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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. | |
| 23313811 | Derived | Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, Kilgallen B, Bongardt S, Barry A, Kelley L, Gordon C. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014 Jan;73(1):183-90. doi: 10.1136/annrheumdis-2012-202760. Epub 2013 Jan 12. |
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1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3. |
|
| Placebo | Other | Phosphate-buffered Saline (PBS) infusion. |
|
| Response at Week 8 according to a combined response index |
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status. |
| Week 8 |
| Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response. | Week 4 |
| Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response. | Week 8 |
| Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response. | Week 12 |
| Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4 | Baseline, Week 4 |
| Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8 | Baseline, Week 8 |
| Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12 | Baseline, Week 12 |
| Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24 | Baseline, Week 24 |
| Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12 | Baseline, Week 12 |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2 | Baseline, Week 2 |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4 | Baseline, Week 4 |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8 | Baseline, Week 8 |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12 | Baseline, Week 12 |
| Change from baseline in physician global assessment at Week 12 | Baseline, Week 12 |
| Change from baseline in patient global assessment at Week 12 | Baseline, Week 12 |
| Short Form-36 (SF-36) response at Week 2 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores. | Baseline, Week 2 |
| Short Form-36 (SF-36) response at Week 4 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores | Baseline, Week 4 |
| Short Form-36 (SF-36) response at Week 8 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores | Baseline, Week 8 |
| Short Form-36 (SF-36) response at Week 12 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores | Baseline, Week 12 |
| European Quality of Life-5 Dimensions (EQ-5D) score at Week 12 | Week 12 |
| Time to first sustained British Isles Lupus Assessment Group (BILAG) response | From Baseline to Week 12 |
| Time to enhanced British Isles Lupus Assessment Group (BILAG) response | From Baseline to Week 12 |
| Treatment failure up to Week 12 | Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids. | From Baseline to Week 12 |
| Cumulative steroid dose at Week 12 | From Baseline to Week 12 |
| Human anti-human antibodies (HAHA) levels at Week 12 | Week 12 |
| Change from baseline in levels of circulating B cells at Week 12 | Baseline, Week 12 |
| Change from baseline in levels of circulating T cells at Week 12 | Baseline, Week 12 |
| 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 |
| Aventura | Florida | United States |
| Tampa | Florida | United States |
| Baltimore | Maryland | United States |
| Brooklyn | New York | 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 |
| Dallas | Texas | United States |
| Arlington | Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Brussels | Belgium |
| Leuven | Belgium |
| Curitiba | Brazil |
| Goiânia | Brazil |
| Porto Alegre | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| Sorocaba | Brazil |
| Chai Wan | Hong Kong |
| Shatin | Hong Kong |
| Debrecen | Hungary |
| Zalaegerszeg | Hungary |
| Bangalore | India |
| Hyderabad | India |
| Ludhiana | India |
| Madurai | 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 |
| Valencia | 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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