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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT #: 2005-000706-31 |
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The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epratuzumab | Active Comparator | 360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion |
|
| Placebo | Placebo Comparator | Intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epratuzumab | Drug | 360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with complete response or partial response; | ||
| Individual BILAG assessments; | ||
| Physician and patient assessment scores; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Barry | UCB Pharma | 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. |
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| Placebo |
| Other |
Intravenous |
|
| Time-to treatment failure; |
| Successful steroid reduction by weeks 20 and 24; |
| Maintenance of steroid reduction at 24 and 48 weeks; |
| Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; |
| Assess epratuzumab on Health-related quality of life |
| Tucson |
| Arizona |
| United States |
| Los Angeles | California | United States |
| Upland | California | United States |
| Colorado Springs | Colorado | United States |
| Denver | Colorado | United States |
| Farmington | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Aventura | Florida | United States |
| Chicago | Illinois | United States |
| Baltimore | Maryland | United States |
| New York | New York | United States |
| Plainview | New York | United States |
| Rochester | New York | United States |
| Syracuse | New York | United States |
| The Bronx | New York | United States |
| Durham | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Gallipolis | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Dallas | Texas | United States |
| Arlington | Virginia | United States |
| Edmonds | Washington | United States |
| Brussels | Belgium |
| Liège | Belgium |
| Rio de Janeiro | Rio de Janeiro | Brazil |
| Goiânia | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| Sorocaba | Brazil |
| Winnipeg | Manitoba | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| Hradec Králové | Czechia |
| Olomouc | Czechia |
| Prague | Czechia |
| Paris | France |
| Toulouse | France |
| Erlangen | Germany |
| Heidelberg | Germany |
| Mannheim | Germany |
| München | Germany |
| Ancona | Italy |
| Brescia | Italy |
| Amsterdam | Netherlands |
| Groningen | Netherlands |
| Leiden | Netherlands |
| Barcelona | Spain |
| Madrid | Spain |
| San Cristóbal de La Laguna | Spain |
| Santander | Spain |
| Seville | Spain |
| Leeds | West Yorkshire | United Kingdom |
| Birmingham | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Sheffield | United Kingdom |
| United Kingdom | 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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