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

PHASE3CompletedINTERVENTIONAL
Enrollment

793

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Epratuzumab

600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles

DRUG

Epratuzumab

1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

DRUG

Placebo

Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles

Trial Locations (141)

Unknown

069, Birmingham

063, Little Rock

085, Escondido

031, Los Angeles

051, Los Angeles

089, Los Angeles

074, San Diego

80, San Gabriel

048, Aurora

037, Colorado Springs

039, Farmington

042, Aventura

090, Clearwater

092, DeBary

064, Jupiter

082, Miami

070, Ormond Beach

084, Palm Harbor

062, Tamarac

050, Tampa

087, Vero Beach

044, Lawrenceville

052, Chicago

096, Indianapolis

060, Shreveport

040, Baltimore

047, Saint Clair Shores

067, Las Cruces

053, New York

077, Charlotte

058, Durham

061, Columbus

071, Middleburg Heights

041, Oklahoma City

076, Oklahoma City

097, Oklahoma City

032, Duncansville

093, Philadelphia

073, Pittsburgh

094, Pittsburgh

099, Charleston

001, Columbia

034, Simpsonville

057, Memphis

078, Austin

098, Austin

079, Dallas

055, Houston

036, Mesquite

066, San Antonio

426, Maroochydore

425, Malvern

429, Camperdown

427, Clayton

430, Liverpool

106, Brussels

107, Brussels

105, Leuven

104, Liège

455, Campinas

453, Porto Alegre

451, Recife

450, Rio de Janeiro

452, Salvador

454, São Paulo

201, Plovdiv

200, Sofia

202, Sofia

203, Sofia

204, Sofia

205, Sofia

218, Olomouc

216, Prague

215, Zlín

226, Tallinn

113, Lille

114, Nantes

112, Paris

116, Pessac

127, Berlin

128, Frankfurt

126, Freiburg im Breisgau

130, Hanover

129, Plochingen

351, Bangalore

352, Hyderabad

350, Lucknow

378, Ashkelon

376, Beersheba

375, Haifa

377, Haifa

381, Jerusalem

382, Kfar Saba

380, Rehovot

379, Tel Aviv

383, Tel Litwinsky

149, Ferrara

148, Padua

147, Torino

155, Kaunas

156, Klaipėda

475, Guadalajara

476, Guadalajara

478, Guadalajara

480, Mérida

091, Cidra

086, San Juan

263, Brasov

260, Bucharest

262, Bucharest

264, Bucharest

261, Cluj-Napoca

285, Petrozavodsk

284, Saint Petersburg

281, Yekaterinburg

306, Busan

303, Daegu

309, Daegu

308, Daejeon

304, Incheon

310, Jeonju

301, Junggu

307, Seoul

302, Suwon

165, San Cristóbal de La Laguna

164, Bilbao

161, Barcelona

162, Madrid

163, Madrid

166, Málaga

177, Santander

160, Seville

325, Changhua

326, Chiayi City

328, Kaohsiung City

329, Taichung

330, Taipei

178, Brighton

182, Doncaster

179, Leeds

181, Romford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY