Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
NCT ID: NCT01262365
Last Updated: 2018-09-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
793 participants
INTERVENTIONAL
2010-12-31
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
NCT01261793
Study of Epratuzumab in Systemic Lupus Erythematosus
NCT00111306
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
NCT00624351
Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
NCT00383214
Study of Epratuzumab in Systemic Lupus Erythematosus
NCT00383513
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo (Weekly infusion)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Epratuzumab 1200 mg every other week
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 SLEDAI total score.
* On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCb Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
069
Birmingham, Alabama, United States
063
Little Rock, Arkansas, United States
085
Escondido, California, United States
031
Los Angeles, California, United States
051
Los Angeles, California, United States
089
Los Angeles, California, United States
074
San Diego, California, United States
80
San Gabriel, California, United States
048
Aurora, Colorado, United States
037
Colorado Springs, Colorado, United States
039
Farmington, Connecticut, United States
042
Aventura, Florida, United States
090
Clearwater, Florida, United States
092
DeBary, Florida, United States
064
Jupiter, Florida, United States
082
Miami, Florida, United States
070
Ormond Beach, Florida, United States
084
Palm Harbor, Florida, United States
062
Tamarac, Florida, United States
050
Tampa, Florida, United States
087
Vero Beach, Florida, United States
044
Lawrenceville, Georgia, United States
052
Chicago, Illinois, United States
096
Indianapolis, Indiana, United States
060
Shreveport, Louisiana, United States
040
Baltimore, Maryland, United States
047
Saint Clair Shores, Michigan, United States
067
Las Cruces, New Mexico, United States
053
New York, New York, United States
077
Charlotte, North Carolina, United States
058
Durham, North Carolina, United States
061
Columbus, Ohio, United States
071
Middleburg Heights, Ohio, United States
041
Oklahoma City, Oklahoma, United States
076
Oklahoma City, Oklahoma, United States
097
Oklahoma City, Oklahoma, United States
032
Duncansville, Pennsylvania, United States
093
Philadelphia, Pennsylvania, United States
073
Pittsburgh, Pennsylvania, United States
094
Pittsburgh, Pennsylvania, United States
099
Charleston, South Carolina, United States
001
Columbia, South Carolina, United States
034
Simpsonville, South Carolina, United States
057
Memphis, Tennessee, United States
078
Austin, Texas, United States
098
Austin, Texas, United States
079
Dallas, Texas, United States
055
Houston, Texas, United States
036
Mesquite, Texas, United States
066
San Antonio, Texas, United States
426
Maroochydore, Queensland, Australia
425
Malvern, Victoria, Australia
429
Camperdown, , Australia
427
Clayton, , Australia
430
Liverpool, , Australia
106
Brussels, , Belgium
107
Brussels, , Belgium
105
Leuven, , Belgium
104
Liège, , Belgium
455
Campinas, , Brazil
453
Porto Alegre, , Brazil
451
Recife, , Brazil
450
Rio de Janeiro, , Brazil
452
Salvador, , Brazil
454
São Paulo, , Brazil
201
Plovdiv, , Bulgaria
200
Sofia, , Bulgaria
202
Sofia, , Bulgaria
203
Sofia, , Bulgaria
204
Sofia, , Bulgaria
205
Sofia, , Bulgaria
218
Olomouc, , Czechia
216
Prague, , Czechia
215
Zlín, , Czechia
226
Tallinn, , Estonia
113
Lille, , France
114
Nantes, , France
112
Paris, , France
116
Pessac, , France
127
Berlin, , Germany
128
Frankfurt, , Germany
126
Freiburg im Breisgau, , Germany
130
Hanover, , Germany
129
Plochingen, , Germany
351
Bangalore, , India
352
Hyderabad, , India
350
Lucknow, , India
378
Ashkelon, , Israel
376
Beersheba, , Israel
375
Haifa, , Israel
377
Haifa, , Israel
381
Jerusalem, , Israel
382
Kfar Saba, , Israel
380
Rehovot, , Israel
379
Tel Aviv, , Israel
383
Tel Litwinsky, , Israel
149
Ferrara, , Italy
148
Padua, , Italy
147
Torino, , Italy
155
Kaunas, , Lithuania
156
Klaipėda, , Lithuania
475
Guadalajara, , Mexico
476
Guadalajara, , Mexico
478
Guadalajara, , Mexico
480
Mérida, , Mexico
091
Cidra, , Puerto Rico
086
San Juan, , Puerto Rico
263
Brasov, , Romania
260
Bucharest, , Romania
262
Bucharest, , Romania
264
Bucharest, , Romania
261
Cluj-Napoca, , Romania
285
Petrozavodsk, , Russia
284
Saint Petersburg, , Russia
281
Yekaterinburg, , Russia
306
Busan, , South Korea
303
Daegu, , South Korea
309
Daegu, , South Korea
308
Daejeon, , South Korea
304
Incheon, , South Korea
310
Jeonju, , South Korea
301
Junggu, , South Korea
307
Seoul, , South Korea
302
Suwon, , South Korea
165
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
164
Bilbao, Vizcaya, Spain
161
Barcelona, , Spain
162
Madrid, , Spain
163
Madrid, , Spain
166
Málaga, , Spain
177
Santander, , Spain
160
Seville, , Spain
325
Changhua, , Taiwan
326
Chiayi City, , Taiwan
328
Kaohsiung City, , Taiwan
329
Taichung, , Taiwan
330
Taipei, , Taiwan
178
Brighton, , United Kingdom
182
Doncaster, , United Kingdom
179
Leeds, , United Kingdom
181
Romford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gottenberg JE, Dorner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjogren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.
Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczynski P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-018563-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SL0009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.