Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
- Registration Number
- NCT01262365
- Lead Sponsor
- UCB Pharma
- Brief Summary
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 793
- 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 SLEDAI total score.
- On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epratuzumab 1200 mg every other week Placebo 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 Placebo (Weekly infusion) Placebo Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles Epratuzumab 600 mg per week 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 Epratuzumab 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
- Primary Outcome Measures
Name Time Method The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index At Week 48 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Daily Corticosteroid Dose at Week 48 At Week 48 Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
Change From Baseline in Daily Corticosteroid Dose at Week 24 At Week 24 Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index At Week 12 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index At Week 24 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index At Week 36 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Trial Locations
- Locations (141)
455
🇧🇷Campinas, Brazil
031
🇺🇸Los Angeles, California, United States
040
🇺🇸Baltimore, Maryland, United States
094
🇺🇸Pittsburgh, Pennsylvania, United States
001
🇺🇸Columbia, South Carolina, United States
079
🇺🇸Dallas, Texas, United States
077
🇺🇸Charlotte, North Carolina, United States
127
🇩🇪Berlin, Germany
427
🇦🇺Clayton, Australia
071
🇺🇸Middleburg Heights, Ohio, United States
106
🇧🇪Brussels, Belgium
107
🇧🇪Brussels, Belgium
105
🇧🇪Leuven, Belgium
099
🇺🇸Charleston, South Carolina, United States
057
🇺🇸Memphis, Tennessee, United States
104
🇧🇪Liege, Belgium
430
🇦🇺Liverpool, Australia
450
🇧🇷Rio de Janeiro, Brazil
129
🇩🇪Plochingen, Germany
034
🇺🇸Simpsonville, South Carolina, United States
216
🇨🇿Praha 2, Czechia
451
🇧🇷Recife, Brazil
112
🇫🇷Paris, France
426
🇦🇺Maroochydore, Queensland, Australia
429
🇦🇺Camperdown, Australia
425
🇦🇺Malvern, Victoria, Australia
453
🇧🇷Porto Alegre, Brazil
454
🇧🇷Sao Paulo, Brazil
452
🇧🇷Salvador, Brazil
128
🇩🇪Frankfurt, Germany
161
🇪🇸Barcelona, Spain
163
🇪🇸Madrid, Spain
218
🇨🇿Olomouc, Czechia
178
🇬🇧Brighton, United Kingdom
164
🇪🇸Bilbao, Vizcaya, Spain
307
🇰🇷Seoul, Korea, Republic of
165
🇪🇸La Laguna, Santa Cruz De Tenerife, Spain
091
🇵🇷Cidra, Puerto Rico
166
🇪🇸Malaga, Spain
162
🇪🇸Madrid, Spain
160
🇪🇸Sevilla, Spain
177
🇪🇸Santander, Spain
055
🇺🇸Houston, Texas, United States
80
🇺🇸San Gabriel, California, United States
089
🇺🇸Los Angeles, California, United States
042
🇺🇸Aventura, Florida, United States
062
🇺🇸Tamarac, Florida, United States
047
🇺🇸Saint Clair Shores, Michigan, United States
215
🇨🇿Zlin, Czechia
203
🇧🇬Sofia, Bulgaria
350
🇮🇳Lucknow, India
306
🇰🇷Busan, Korea, Republic of
301
🇰🇷Junggu, Korea, Republic of
302
🇰🇷Suwon, Korea, Republic of
304
🇰🇷Incheon, Korea, Republic of
262
🇷🇴Bucharest, Romania
264
🇷🇴Bucharest, Romania
261
🇷🇴Cluj-Napoca, Romania
181
🇬🇧Romford, United Kingdom
182
🇬🇧Doncaster, United Kingdom
058
🇺🇸Durham, North Carolina, United States
066
🇺🇸San Antonio, Texas, United States
037
🇺🇸Colorado Springs, Colorado, United States
051
🇺🇸Los Angeles, California, United States
085
🇺🇸Escondido, California, United States
074
🇺🇸San Diego, California, United States
052
🇺🇸Chicago, Illinois, United States
096
🇺🇸Indianapolis, Indiana, United States
044
🇺🇸Lawrenceville, Georgia, United States
067
🇺🇸Las Cruces, New Mexico, United States
053
🇺🇸New York, New York, United States
061
🇺🇸Columbus, Ohio, United States
078
🇺🇸Austin, Texas, United States
093
🇺🇸Philadelphia, Pennsylvania, United States
073
🇺🇸Pittsburgh, Pennsylvania, United States
098
🇺🇸Austin, Texas, United States
032
🇺🇸Duncansville, Pennsylvania, United States
036
🇺🇸Mesquite, Texas, United States
179
🇬🇧Leeds, United Kingdom
048
🇺🇸Aurora, Colorado, United States
069
🇺🇸Birmingham, Alabama, United States
041
🇺🇸Oklahoma City, Oklahoma, United States
076
🇺🇸Oklahoma City, Oklahoma, United States
097
🇺🇸Oklahoma City, Oklahoma, United States
082
🇺🇸Miami, Florida, United States
204
🇧🇬Sofia, Bulgaria
382
🇮🇱Kfar Saba, Israel
303
🇰🇷Daegu, Korea, Republic of
156
🇱🇹Klaipeda, Lithuania
086
🇵🇷San Juan, Puerto Rico
260
🇷🇴Bucharest, Romania
326
🇨🇳Chiayi City, Taiwan
039
🇺🇸Farmington, Connecticut, United States
201
🇧🇬Plovdiv, Bulgaria
226
🇪🇪Tallinn, Estonia
113
🇫🇷Lille, France
090
🇺🇸Clearwater, Florida, United States
060
🇺🇸Shreveport, Louisiana, United States
092
🇺🇸DeBary, Florida, United States
064
🇺🇸Jupiter, Florida, United States
087
🇺🇸Vero Beach, Florida, United States
200
🇧🇬Sofia, Bulgaria
202
🇧🇬Sofia, Bulgaria
084
🇺🇸Palm Harbor, Florida, United States
050
🇺🇸Tampa, Florida, United States
114
🇫🇷Nantes, France
116
🇫🇷Pessac, France
351
🇮🇳Bangalore, India
376
🇮🇱Beer Sheva, Israel
375
🇮🇱Haifa, Israel
377
🇮🇱Haifa, Israel
285
🇷🇺Petrozavodsk, Russian Federation
284
🇷🇺Saint Petersburg, Russian Federation
205
🇧🇬Sofia, Bulgaria
381
🇮🇱Jerusalem, Israel
379
🇮🇱Tel Aviv, Israel
383
🇮🇱Tel-Hashomer, Israel
155
🇱🇹Kaunas, Lithuania
475
🇲🇽Guadalajara, Mexico
478
🇲🇽Guadalajara, Mexico
325
🇨🇳Changhua, Taiwan
328
🇨🇳Kaohsiung, Taiwan
329
🇨🇳Taichung, Taiwan
070
🇺🇸Ormond Beach, Florida, United States
130
🇩🇪Hannover, Germany
352
🇮🇳Hyderabad, India
378
🇮🇱Ashkelon, Israel
309
🇰🇷Daegu, Korea, Republic of
476
🇲🇽Guadalajara, Mexico
263
🇷🇴Brasov, Romania
281
🇷🇺Ekaterinburg, Russian Federation
126
🇩🇪Freiburg, Germany
380
🇮🇱Rehovot, Israel
149
🇮🇹Ferrara, Italy
148
🇮🇹Padova, Italy
147
🇮🇹Torino, Italy
308
🇰🇷Daejeon, Korea, Republic of
310
🇰🇷Jeonju, Korea, Republic of
480
🇲🇽Mérida, Mexico
330
🇨🇳Taipei, Taiwan
063
🇺🇸Little Rock, Arkansas, United States