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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)

Sponsored by UCB, Inc.

Phase Quota
Phase 3

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

Study Start Date: December 2010

Estimated Completion Date: June 2015

Specialties: Internal Medicine: Clinical Pharmacology,Rheumatology Physician Assistant: Clinical Pharmacology,Rheumatology Rheumatology: Clinical Pharmacology,Systemic Lupus (SLE)

Interventions

  • Drug: Epratuzumab
  • Drug: Placebo

Inclusion criteria

  • Positive antinuclear antibodies (ANA) at Screening (Visit 1)
  • Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
  • Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
  • Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
  • On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion criteria

  • Subjects who are breastfeeding, pregnant, or plan to become pregnant
  • Subjects with active, severe SLE disease activity which involves the renal system
  • Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease
  • Subjects with the evidence of an immunosuppressive state
  • Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
  • History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
  • Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1)
  • Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
  • Subjects with substance abuse or dependence or other relevant concurrent medical condition
  • Subjects with history of thromboembolic events within 1 year of screening Visit
  • Subjects with significant hematologic abnormalities
  • Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
  • Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
  • Subject has previously participated in this study or has previously received epratuzumab treatment

Study Locations And Contact Information

  • 852, Ahmedabad
  • 678, Christchurch
  • 749, Warsaw
  • 535, Charleston South Carolina
  • 744, Czestochowa
  • 514, Brandon Florida
  • 594, Westlake Village California
  • 954, Belo Horizonte
  • 534, Seattle Washington
  • 575, Florissant Missouri
  • 717, Debrecen
  • 518, Plantation Florida
  • 759, Constanta
  • 562, San Antonio Texas
  • 903, Stellenbosch
  • 576, New Orleans Louisiana
  • 677, Birmingham
  • 559, Charlotte North Carolina
  • 952, Rio de Janeiro
  • 531, San Leandro California
  • 626, Leipzig
  • 596, Nashua New Hampshire
  • 756, Galati
  • 618, Limoges Cedex
  • 558, Torrance California
  • 613, Caen
  • 589, San Diego California
  • 758, Bucharest
  • 515, Hemet California
  • 639, Wiesbaden
  • 515, Hemet California
  • 549, St Louis Missouri
  • 538, Tampa Florida
  • 976, Mexico D.F.
  • 981, Torreon
  • 761, Iasi
  • 592, Lexington Kentucky
  • 634, Schwarting
  • 750, Lublin
  • 779, Moscow
  • 550, La Jolla California
  • 633, Berlin
  • 956, Campinas
  • 561, Wyomissing Pennsylvania
  • 794, Kiev
  • 626, Leipzig
  • 758, Bucharest
  • 628, Berlin
  • 561, Wyomissing Pennsylvania
  • 637, Hamburg
  • 713, Zalaegerszeg
  • 627, Münster
  • 796, Vinnytsya
  • 598, Myrtle Beach South Carolina
  • 663, Santiago de Compostela
  • 507, Mississauga Ontario
  • 647, Pisa
  • 955, Gioania
  • 548, Los Angeles Louisiana
  • 557, Little Rock Arkansas
  • 508, Rimouski Quebec
  • 790, Kiyv
  • 599, Lansing Michigan
  • 511, Bridgeport Connecticut
  • 596, Nashua New Hampshire
  • 543, Bowling Green Kentucky
  • 593, Clifton New Jersey
  • 552, Chesapeake Virginia
  • 745, Katowice
  • 743, Bydgoszcz
  • 574, Amarillo Texas
  • 760, Bucharest
  • 544, Huntington Beach California
  • 761, Iasi
  • 550, La Jolla California
  • 633, Berlin
  • 901, Cape Town
  • 587, Decatur Georgia
  • 902, Durban
  • 592, Lexington Kentucky
  • 791, Donetsk
  • 554, Ann Arbor Michigan
  • 577, Roslyn New York
  • 627, Münster
  • 618, Limoges Cedex
  • 756, Galati
  • 568, Freehold New Jersey
  • 629, Kiel
  • 716, Budapest
  • 617, Montpellier Cedex 5
  • 576, New Orleans Louisiana
  • 585, Port Orange Florida
  • 853, Bangalore
  • 780, Kemerovo
  • 747, Szczecin
  • 711, Szeged
  • 598, Myrtle Beach South Carolina
  • 502, Hamilton
  • 713, Zalaegerszeg
  • 793, Odessa
  • 639, Wiesbaden
  • 513, Lansing Michigan
  • 629, Kiel
  • 981, Torreon
  • 533, Fort Lauderdale Florida
  • 950, Juiz de Fora
  • 636, Dessau-Roblau
  • 711, Szeged
  • 547, Tulsa Oklahoma
  • 506, St. John's Newfoundland and Labrador
  • 585, Port Orange Florida
  • 537, Atlanta Georgia
  • 563, Houston Texas
  • 632, Herne
  • 679, London
  • 718, Budapest
  • 760, Bucharest
  • 982, Mexico
  • 852, Ahmedabad
  • 746, Katowice
  • 662, Las Palmas de Gran Canaria
  • 577, Roslyn New York
  • 517, Victoria
  • 594, Westlake Village California
  • 752, Elblag
  • 976, Mexico D.F.
  • 790, Kiyv
  • 794, Kiev
  • 749, Warsaw
  • 553, Lake Success New York
  • 901, Cape Town
  • 590, Idaho Falls Idaho
  • 677, Birmingham
  • 500, London
  • 659, Vigo
  • 553, Lake Success New York
  • 517, Victoria
  • 614, Paris
  • 531, San Leandro California
  • 562, San Antonio Texas
  • 511, Bridgeport Connecticut
  • 718, Budapest
  • 599, Lansing Michigan
  • 616, Toulouse Cedex 9
  • 513, Lansing Michigan
  • 557, Little Rock Arkansas
  • 558, Torrance California
  • 616, Toulouse Cedex 9
  • 514, Brandon Florida
  • 797, Kiev
  • 751, Ustron
  • 716, Budapest
  • 636, Dessau-Roblau
  • 793, Odessa
  • 664, Madrid
  • 660, Getafe
  • 712, Budapest
  • 541, Houston Texas
  • 537, Atlanta Georgia
  • 715, Szeged
  • 792, Luhansk
  • 628, Berlin
  • 502, Hamilton
  • 500, London
  • 661, Barcelona
  • 778, Kemerovo
  • 590, Idaho Falls Idaho
  • 504, Toronto
  • 589, San Diego California
  • 572, Boston Massachusetts
  • 552, Chesapeake Virginia
  • 544, Huntington Beach California
  • 625, Köln
  • 712, Budapest
  • 982, Mexico
  • 746, Katowice
  • 613, Caen
  • 547, Tulsa Oklahoma
  • 532, Denver Colorado
  • 759, Constanta
  • 518, Plantation Florida
  • 779, Moscow
  • 792, Luhansk
  • 748, Lublin
  • 743, Bydgoszcz
  • 545, Manhasset New York
  • 571, Jackson Tennessee
  • 780, Kemerovo
  • 575, Florissant Missouri
  • 853, Bangalore
  • 978, Del Cuauhtemoc
  • 744, Czestochowa
  • 587, Decatur Georgia
  • 679, London
  • 551, Brooklyn New York
  • 574, Amarillo Texas
  • 791, Donetsk
  • 796, Vinnytsya
  • 506, St. John's Newfoundland and Labrador
  • 903, Stellenbosch
  • 678, Christchurch
  • 751, Ustron
  • 631, Zerbst
  • 541, Houston Texas
  • 660, Getafe
  • 572, Boston Massachusetts
  • 625, Köln
  • 747, Szczecin
  • 955, Gioania
  • 532, Denver Colorado
  • 539, Birmingham Alabama
  • 661, Barcelona
  • 559, Charlotte North Carolina
  • 535, Charleston South Carolina
  • 902, Durban
  • 614, Paris
  • 662, Las Palmas de Gran Canaria
  • 504, Toronto
  • 543, Bowling Green Kentucky
  • 954, Belo Horizonte
  • 742, Poznan
  • 663, Santiago de Compostela
  • 538, Tampa Florida
  • 797, Kiev
  • 534, Seattle Washington
  • 742, Poznan
  • 646, Roma
  • 634, Schwarting
  • 570, Austin Texas
  • 648, Milano
  • 548, Los Angeles Louisiana
  • 717, Debrecen
  • 549, St Louis Missouri
  • 545, Manhasset New York
  • 563, Houston Texas
  • 748, Lublin
  • 617, Montpellier Cedex 5
  • 631, Zerbst
  • 664, Madrid
  • 539, Birmingham Alabama
  • 632, Herne
  • 750, Lublin
  • 659, Vigo
  • 648, Milano
  • 778, Kemerovo
  • 956, Campinas
  • 646, Roma
  • 554, Ann Arbor Michigan
  • 570, Austin Texas
  • 950, Juiz de Fora
  • 637, Hamburg
  • 533, Fort Lauderdale Florida
  • 757, Bucharest
  • 715, Szeged
  • 551, Brooklyn New York
  • 593, Clifton New Jersey
  • 647, Pisa
  • 757, Bucharest
  • 752, Elblag
  • 508, Rimouski Quebec
  • 952, Rio de Janeiro
  • 507, Mississauga Ontario
  • 571, Jackson Tennessee
  • 568, Freehold New Jersey
  • 978, Del Cuauhtemoc
  • 745, Katowice

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