Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
EMBODY4
A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
2 other identifiers
interventional
1,250
24 countries
227
Brief Summary
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
Longer than P75 for phase_3
227 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
October 3, 2018
CompletedOctober 3, 2018
March 1, 2016
4.6 years
August 1, 2011
July 20, 2018
September 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
During the treatment period (through Week 96)
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
During the treatment period (through Week 96)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization
During the treatment period (through Week 96)
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization
During the treatment period (through Week 96)
Secondary Outcomes (4)
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
At Week 48
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Week 48
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Week 96
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Week 96
Study Arms (2)
Epratuzumab 600 mg per week
EXPERIMENTAL600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Epratuzumab 1200 mg every other week
EXPERIMENTAL1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Interventions
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Eligibility Criteria
You may qualify if:
- Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
- Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
- Women of childbearing potential must agree to use an acceptable method of birth control
You may not qualify if:
- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
- Subjects with active, severe SLE disease activity which involves the renal system
- Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
- Substance abuse or dependence
- History of malignant cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (228)
539
Birmingham, Alabama, United States
557
Little Rock, Arkansas, United States
515
Hemet, California, United States
544
Huntington Beach, California, United States
550
La Jolla, California, United States
031
Los Angeles, California, United States
051
Los Angeles, California, United States
089
Los Angeles, California, United States
531
San Leandro, California, United States
594
Thousand Oaks, California, United States
558
Torrance, California, United States
048
Aurora, Colorado, United States
037
Colorado Springs, Colorado, United States
532
Denver, Colorado, United States
511
Bridgeport, Connecticut, United States
039
Farmington, Connecticut, United States
042
Aventura, Florida, United States
514
Brandon, Florida, United States
090
Clearwater, Florida, United States
092
DeBary, Florida, United States
533
Fort Lauderdale, Florida, United States
064
Jupiter, Florida, United States
070
Ormond Beach, Florida, United States
084
Palm Harbor, Florida, United States
518
Plantation, Florida, United States
585
Port Orange, Florida, United States
050
Tampa, Florida, United States
538
Tampa, Florida, United States
087
Vero Beach, Florida, United States
537
Atlanta, Georgia, United States
044
Duluth, Georgia, United States
590
Idaho Falls, Idaho, United States
052
Chicago, Illinois, United States
096
Indianapolis, Indiana, United States
060
Shreveport, Louisiana, United States
513
Lansing, Michigan, United States
599
Lansing, Michigan, United States
047
Saint Clair Shores, Michigan, United States
575
Florissant, Missouri, United States
549
St Louis, Missouri, United States
596
Nashua, New Hampshire, United States
568
Freehold, New Jersey, United States
593
Trenton, New Jersey, United States
067
Las Cruces, New Mexico, United States
551
Brooklyn, New York, United States
553
Great Neck, New York, United States
545
Manhasset, New York, United States
053
New York, New York, United States
577
Roslyn, New York, United States
077
Charlotte, North Carolina, United States
559
Charlotte, North Carolina, United States
058
Durham, North Carolina, United States
075
Wilmington, 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
547
Tulsa, Oklahoma, United States
032
Duncansville, Pennsylvania, United States
093
Philadelphia, Pennsylvania, United States
073
Pittsburgh, Pennsylvania, United States
094
Pittsburgh, Pennsylvania, United States
535
Charleston, South Carolina, United States
598
Myrtle Beach, South Carolina, United States
571
Jackson, Tennessee, United States
057
Memphis, Tennessee, United States
574
Amarillo, Texas, United States
078
Austin, Texas, United States
098
Austin, Texas, United States
570
Austin, Texas, United States
079
Dallas, Texas, United States
541
Houston, Texas, United States
563
Houston, Texas, United States
036
Mesquite, Texas, United States
066
San Antonio, Texas, United States
562
San Antonio, Texas, United States
534
Seattle, Washington, United States
429
Camperdown, Australia
427
Clayton, Australia
430
Liverpool, Australia
425
Malvern, Australia
426
Maroochydore, Australia
106
Brussels, Belgium
107
Brussels, Belgium
105
Leuven, Belgium
104
Liège, Belgium
954
Belo Horizonte, Brazil
956
Campinas, Brazil
955
Goiânia, Brazil
950
Juiz de Fora, Brazil
453
Porto Alegre, Brazil
451
Recife, Brazil
450
Rio de Janeiro, Brazil
952
Rio de Janeiro, Brazil
452
Salvador, Brazil
454
São Paulo, Brazil
200
Sofia, Bulgaria
202
Sofia, Bulgaria
203
Sofia, Bulgaria
204
Sofia, Bulgaria
205
Sofia, Bulgaria
500
London, Ontario, Canada
502
Hamilton, Canada
507
Mississauga, Canada
508
Rimouski, Canada
506
St. John's, Canada
504
Toronto, Canada
218
Olomouc, Czechia
216
Prague, Czechia
215
Zlín, Czechia
226
Tallinn, Estonia
113
Lille, France
618
Limoges, France
617
Montpellier, France
614
Paris, France
116
Pessac, France
616
Toulouse, France
127
Berlin, Germany
628
Berlin, Germany
633
Berlin, Germany
625
Cologne, Germany
128
Frankfurt, Germany
126
Freiburg im Breisgau, Germany
637
Hamburg, Germany
632
Herne, Germany
626
Leipzig, Germany
634
Mainz, Germany
627
Münster, Germany
129
Plochingen, Germany
636
Roßlau, Germany
631
Zerbst, Germany
349
Shatin, Hong Kong
712
Budapest, Hungary
716
Budapest, Hungary
718
Budapest, Hungary
717
Debrecen, Hungary
711
Szeged, Hungary
715
Szeged, Hungary
713
Zalaegerszeg, Hungary
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
648
Milan, Italy
148
Padua, Italy
647
Pisa, Italy
646
Roma, Italy
147
Torino, Italy
242
Kaunas, Lithuania
244
Klaipėda, Lithuania
243
Vilnius, Lithuania
478
Guadalajara, Mexico
976
Mexico City, Mexico
982
Mexico City, Mexico
480
Mérida, Mexico
981
Torreón, Mexico
743
Bydgoszcz, Poland
744
Częstochowa, Poland
752
Elblag, Poland
754
Elblag, Poland
746
Katowice, Poland
748
Lublin, Poland
750
Lublin, Poland
742
Poznan, Poland
747
Szczecin, Poland
751
Ustroń, Poland
749
Warsaw, Poland
263
Brasov, Romania
260
Bucharest, Romania
262
Bucharest, Romania
264
Bucharest, Romania
757
Bucharest, Romania
758
Bucharest, Romania
261
Cluj-Napoca, Romania
759
Constanța, Romania
756
Galati, Romania
761
Iași, Romania
779
Moscow, Russia
285
Petrozavodsk, Russia
284
Saint Petersburg, Russia
281
Yekaterinburg, Russia
901
Cape Town, South Africa
902
Durban, South Africa
903
Stellenbosch, South Africa
306
Busan, South Korea
303
Daegu, South Korea
308
Daejeon, South Korea
301
Incheon, South Korea
307
Seoul, South Korea
302
Suwon, South Korea
161
Barcelona, Spain
661
Barcelona, Spain
164
Bilbao, Spain
660
Getafe, Spain
662
Las Palmas de Gran Canaria, Spain
162
Madrid, Spain
163
Madrid, Spain
664
Madrid, Spain
166
Málaga, Spain
165
San Cristóbal de La Laguna, Spain
177
Santander, Spain
663
Santiago de Compostela, Spain
160
Seville, Spain
659
Vigo, Spain
325
Changhua, Taiwan
326
Chiayi City, Taiwan
328
Kaohsiung City, Taiwan
330
Taipei, Taiwan
791
Donetsk, Ukraine
799
Ivano-Frankivsk, Ukraine
790
Kiev, Ukraine
794
Kiev, Ukraine
797
Kiev, Ukraine
792
Luhansk, Ukraine
793
Odesa, Ukraine
796
Vinnytsia, Ukraine
677
Birmingham, United Kingdom
178
Brighton, United Kingdom
182
Doncaster, United Kingdom
179
Leeds, United Kingdom
181
Romford, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 3, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
October 3, 2018
Results First Posted
October 3, 2018
Record last verified: 2016-03