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Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (EMBODY4)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epratuzumab
Epratuzumab
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, Monoclonal antibody, B-Cell immunotherapy, Epratuzumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion

Sites / Locations

  • 539
  • 557
  • 515
  • 544
  • 550
  • 031
  • 051
  • 089
  • 531
  • 594
  • 558
  • 048
  • 037
  • 532
  • 511
  • 039
  • 042
  • 514
  • 090
  • 092
  • 533
  • 064
  • 070
  • 084
  • 518
  • 585
  • 050
  • 538
  • 087
  • 537
  • 044
  • 590
  • 052
  • 096
  • 060
  • 513
  • 599
  • 047
  • 575
  • 549
  • 596
  • 568
  • 593
  • 067
  • 551
  • 553
  • 545
  • 053
  • 577
  • 077
  • 559
  • 058
  • 075
  • 061
  • 071
  • 041
  • 076
  • 097
  • 547
  • 032
  • 093
  • 073
  • 094
  • 535
  • 598
  • 571
  • 057
  • 574
  • 078
  • 098
  • 570
  • 079
  • 541
  • 563
  • 036
  • 066
  • 562
  • 534
  • 429
  • 427
  • 430
  • 425
  • 426
  • 106
  • 107
  • 105
  • 104
  • 954
  • 956
  • 955
  • 950
  • 453
  • 451
  • 450
  • 952
  • 452
  • 454
  • 200
  • 202
  • 203
  • 204
  • 205
  • 500
  • 502
  • 507
  • 508
  • 506
  • 504
  • 218
  • 216
  • 215
  • 226
  • 113
  • 618
  • 617
  • 614
  • 116
  • 616
  • 127
  • 628
  • 633
  • 128
  • 126
  • 637
  • 632
  • 625
  • 626
  • 634
  • 627
  • 129
  • 636
  • 631
  • 349
  • 712
  • 716
  • 718
  • 717
  • 711
  • 715
  • 713
  • 378
  • 376
  • 375
  • 377
  • 381
  • 382
  • 380
  • 379
  • 383
  • 149
  • 648
  • 148
  • 647
  • 646
  • 147
  • 306
  • 303
  • 308
  • 301
  • 307
  • 302
  • 242
  • 244
  • 243
  • 478
  • 480
  • 976
  • 982
  • 981
  • 743
  • 744
  • 752
  • 754
  • 746
  • 748
  • 750
  • 742
  • 747
  • 751
  • 749
  • 263
  • 260
  • 262
  • 264
  • 757
  • 758
  • 261
  • 759
  • 756
  • 761
  • 281
  • 779
  • 285
  • 284
  • 901
  • 902
  • 903
  • 161
  • 661
  • 164
  • 660
  • 165
  • 662
  • 162
  • 163
  • 664
  • 166
  • 177
  • 663
  • 160
  • 659
  • 325
  • 326
  • 328
  • 330
  • 791
  • 799
  • 790
  • 794
  • 797
  • 792
  • 793
  • 796
  • 677
  • 178
  • 182
  • 179
  • 181

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Epratuzumab 600 mg per week

Epratuzumab 1200 mg every other week

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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
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

Secondary Outcome Measures

Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

Full Information

First Posted
August 1, 2011
Last Updated
September 3, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01408576
Brief Title
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
Acronym
EMBODY4
Official Title
A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
Detailed Description
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus, Monoclonal antibody, B-Cell immunotherapy, Epratuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epratuzumab 600 mg per week
Arm Type
Experimental
Arm Description
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Arm Title
Epratuzumab 1200 mg every other week
Arm Type
Experimental
Arm Description
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Intervention Type
Drug
Intervention Name(s)
Epratuzumab
Intervention Description
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Intervention Type
Drug
Intervention Name(s)
Epratuzumab
Intervention Description
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
Primary Outcome Measure Information:
Title
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Description
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.
Time Frame
During the treatment period (through Week 96)
Title
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Description
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.
Time Frame
During the treatment period (through Week 96)
Title
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Description
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
Time Frame
During the treatment period (through Week 96)
Title
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Description
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
Time Frame
During the treatment period (through Week 96)
Secondary Outcome Measure Information:
Title
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Description
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame
At Week 48
Title
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Description
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame
Week 48
Title
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Description
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame
Week 96
Title
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Description
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame
Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
Facility Name
539
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
557
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
515
City
Hemet
State/Province
California
Country
United States
Facility Name
544
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
550
City
La Jolla
State/Province
California
Country
United States
Facility Name
031
City
Los Angeles
State/Province
California
Country
United States
Facility Name
051
City
Los Angeles
State/Province
California
Country
United States
Facility Name
089
City
Los Angeles
State/Province
California
Country
United States
Facility Name
531
City
San Leandro
State/Province
California
Country
United States
Facility Name
594
City
Thousand Oaks
State/Province
California
Country
United States
Facility Name
558
City
Torrance
State/Province
California
Country
United States
Facility Name
048
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
037
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
532
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
039
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
042
City
Aventura
State/Province
Florida
Country
United States
Facility Name
514
City
Brandon
State/Province
Florida
Country
United States
Facility Name
090
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
092
City
DeBary
State/Province
Florida
Country
United States
Facility Name
533
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
064
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
070
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
084
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
518
City
Plantation
State/Province
Florida
Country
United States
Facility Name
585
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
050
City
Tampa
State/Province
Florida
Country
United States
Facility Name
538
City
Tampa
State/Province
Florida
Country
United States
Facility Name
087
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
537
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
044
City
Duluth
State/Province
Georgia
Country
United States
Facility Name
590
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
052
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
096
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
060
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
513
City
Lansing
State/Province
Michigan
Country
United States
Facility Name
599
City
Lansing
State/Province
Michigan
Country
United States
Facility Name
047
City
Saint Clair Shores
State/Province
Michigan
Country
United States
Facility Name
575
City
Florissant
State/Province
Missouri
Country
United States
Facility Name
549
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
596
City
Nashua
State/Province
New Hampshire
Country
United States
Facility Name
568
City
Freehold
State/Province
New Jersey
Country
United States
Facility Name
593
City
Trenton
State/Province
New Jersey
Country
United States
Facility Name
067
City
Las Cruces
State/Province
New Mexico
Country
United States
Facility Name
551
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
553
City
Great Neck
State/Province
New York
Country
United States
Facility Name
545
City
Manhasset
State/Province
New York
Country
United States
Facility Name
053
City
New York
State/Province
New York
Country
United States
Facility Name
577
City
Roslyn
State/Province
New York
Country
United States
Facility Name
077
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
559
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
058
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
075
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
061
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
071
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
041
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
076
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
097
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
547
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
032
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
093
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
073
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
094
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
535
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
598
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
571
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
057
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
574
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
078
City
Austin
State/Province
Texas
Country
United States
Facility Name
098
City
Austin
State/Province
Texas
Country
United States
Facility Name
570
City
Austin
State/Province
Texas
Country
United States
Facility Name
079
City
Dallas
State/Province
Texas
Country
United States
Facility Name
541
City
Houston
State/Province
Texas
Country
United States
Facility Name
563
City
Houston
State/Province
Texas
Country
United States
Facility Name
036
City
Mesquite
State/Province
Texas
Country
United States
Facility Name
066
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
562
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
534
City
Seattle
State/Province
Washington
Country
United States
Facility Name
429
City
Camperdown
Country
Australia
Facility Name
427
City
Clayton
Country
Australia
Facility Name
430
City
Liverpool
Country
Australia
Facility Name
425
City
Malvern
Country
Australia
Facility Name
426
City
Maroochydore
Country
Australia
Facility Name
106
City
Brussels
Country
Belgium
Facility Name
107
City
Brussels
Country
Belgium
Facility Name
105
City
Leuven
Country
Belgium
Facility Name
104
City
Liege
Country
Belgium
Facility Name
954
City
Belo Horizonte
Country
Brazil
Facility Name
956
City
Campinas
Country
Brazil
Facility Name
955
City
Goiânia
Country
Brazil
Facility Name
950
City
Juiz de Fora
Country
Brazil
Facility Name
453
City
Porto Alegre
Country
Brazil
Facility Name
451
City
Recife
Country
Brazil
Facility Name
450
City
Rio de Janeiro
Country
Brazil
Facility Name
952
City
Rio de Janeiro
Country
Brazil
Facility Name
452
City
Salvador
Country
Brazil
Facility Name
454
City
Sao Paulo
Country
Brazil
Facility Name
200
City
Sofia
Country
Bulgaria
Facility Name
202
City
Sofia
Country
Bulgaria
Facility Name
203
City
Sofia
Country
Bulgaria
Facility Name
204
City
Sofia
Country
Bulgaria
Facility Name
205
City
Sofia
Country
Bulgaria
Facility Name
500
City
London
State/Province
Ontario
Country
Canada
Facility Name
502
City
Hamilton
Country
Canada
Facility Name
507
City
Mississauga
Country
Canada
Facility Name
508
City
Rimouski
Country
Canada
Facility Name
506
City
St. John's
Country
Canada
Facility Name
504
City
Toronto
Country
Canada
Facility Name
218
City
Olomouc
Country
Czechia
Facility Name
216
City
Praha 2
Country
Czechia
Facility Name
215
City
Zlin
Country
Czechia
Facility Name
226
City
Tallinn
Country
Estonia
Facility Name
113
City
Lille Cedex
Country
France
Facility Name
618
City
Limoges Cedex
Country
France
Facility Name
617
City
Montpellier Cedex 5
Country
France
Facility Name
614
City
Paris
Country
France
Facility Name
116
City
Pessac
Country
France
Facility Name
616
City
Toulouse Cedex 9
Country
France
Facility Name
127
City
Berlin
Country
Germany
Facility Name
628
City
Berlin
Country
Germany
Facility Name
633
City
Berlin
Country
Germany
Facility Name
128
City
Frankfurt
Country
Germany
Facility Name
126
City
Freiburg
Country
Germany
Facility Name
637
City
Hamburg
Country
Germany
Facility Name
632
City
Herne
Country
Germany
Facility Name
625
City
Koln
Country
Germany
Facility Name
626
City
Leipzig
Country
Germany
Facility Name
634
City
Mainz
Country
Germany
Facility Name
627
City
Munster
Country
Germany
Facility Name
129
City
Plochingen
Country
Germany
Facility Name
636
City
Roßlau
Country
Germany
Facility Name
631
City
Zerbst
Country
Germany
Facility Name
349
City
Shatin
Country
Hong Kong
Facility Name
712
City
Budapest
Country
Hungary
Facility Name
716
City
Budapest
Country
Hungary
Facility Name
718
City
Budapest
Country
Hungary
Facility Name
717
City
Debrecen
Country
Hungary
Facility Name
711
City
Szeged
Country
Hungary
Facility Name
715
City
Szeged
Country
Hungary
Facility Name
713
City
Zalaegerszeg
Country
Hungary
Facility Name
378
City
Ashkelon
Country
Israel
Facility Name
376
City
Beer Sheva
Country
Israel
Facility Name
375
City
Haifa
Country
Israel
Facility Name
377
City
Haifa
Country
Israel
Facility Name
381
City
Jerusalem
Country
Israel
Facility Name
382
City
Kfar Saba
Country
Israel
Facility Name
380
City
Rehovot
Country
Israel
Facility Name
379
City
Tel Aviv
Country
Israel
Facility Name
383
City
Tel-Hashomer
Country
Israel
Facility Name
149
City
Ferrara
Country
Italy
Facility Name
648
City
Milano
Country
Italy
Facility Name
148
City
Padova
Country
Italy
Facility Name
647
City
Pisa
Country
Italy
Facility Name
646
City
Roma
Country
Italy
Facility Name
147
City
Torino
Country
Italy
Facility Name
306
City
Busan
Country
Korea, Republic of
Facility Name
303
City
Daegu
Country
Korea, Republic of
Facility Name
308
City
Daejeon
Country
Korea, Republic of
Facility Name
301
City
Incheon
Country
Korea, Republic of
Facility Name
307
City
Seoul
Country
Korea, Republic of
Facility Name
302
City
Suwon
Country
Korea, Republic of
Facility Name
242
City
Kaunas
Country
Lithuania
Facility Name
244
City
Klaipeda
Country
Lithuania
Facility Name
243
City
Vilnius
Country
Lithuania
Facility Name
478
City
Guadalajara
Country
Mexico
Facility Name
480
City
Merida
Country
Mexico
Facility Name
976
City
Mexico City
Country
Mexico
Facility Name
982
City
Mexico City
Country
Mexico
Facility Name
981
City
Torreon
Country
Mexico
Facility Name
743
City
Bydgoszcz
Country
Poland
Facility Name
744
City
Czestochowa
Country
Poland
Facility Name
752
City
Elblag
Country
Poland
Facility Name
754
City
Elbląg
Country
Poland
Facility Name
746
City
Katowice
Country
Poland
Facility Name
748
City
Lublin
Country
Poland
Facility Name
750
City
Lublin
Country
Poland
Facility Name
742
City
Poznan
Country
Poland
Facility Name
747
City
Szczecin
Country
Poland
Facility Name
751
City
Ustron
Country
Poland
Facility Name
749
City
Warsaw
Country
Poland
Facility Name
263
City
Brasov
Country
Romania
Facility Name
260
City
Bucharest
Country
Romania
Facility Name
262
City
Bucharest
Country
Romania
Facility Name
264
City
Bucharest
Country
Romania
Facility Name
757
City
Bucharest
Country
Romania
Facility Name
758
City
Bucharest
Country
Romania
Facility Name
261
City
Cluj-Napoca
Country
Romania
Facility Name
759
City
Constanta
Country
Romania
Facility Name
756
City
Galati
Country
Romania
Facility Name
761
City
Iasi
Country
Romania
Facility Name
281
City
Ekaterinburg
Country
Russian Federation
Facility Name
779
City
Moscow
Country
Russian Federation
Facility Name
285
City
Petrozavodsk
Country
Russian Federation
Facility Name
284
City
Saint Petersburg
Country
Russian Federation
Facility Name
901
City
Cape Town
Country
South Africa
Facility Name
902
City
Durban
Country
South Africa
Facility Name
903
City
Stellenbosch
Country
South Africa
Facility Name
161
City
Barcelona
Country
Spain
Facility Name
661
City
Barcelona
Country
Spain
Facility Name
164
City
Bilbao
Country
Spain
Facility Name
660
City
Getafe
Country
Spain
Facility Name
165
City
La Laguna
Country
Spain
Facility Name
662
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
162
City
Madrid
Country
Spain
Facility Name
163
City
Madrid
Country
Spain
Facility Name
664
City
Madrid
Country
Spain
Facility Name
166
City
Malaga
Country
Spain
Facility Name
177
City
Santander
Country
Spain
Facility Name
663
City
Santiago de Compostela
Country
Spain
Facility Name
160
City
Sevilla
Country
Spain
Facility Name
659
City
Vigo
Country
Spain
Facility Name
325
City
Changhua
Country
Taiwan
Facility Name
326
City
Chiayi City
Country
Taiwan
Facility Name
328
City
Kaohsiung City
Country
Taiwan
Facility Name
330
City
Taipei
Country
Taiwan
Facility Name
791
City
Donetsk
Country
Ukraine
Facility Name
799
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
790
City
Kiev
Country
Ukraine
Facility Name
794
City
Kiev
Country
Ukraine
Facility Name
797
City
Kiev
Country
Ukraine
Facility Name
792
City
Lugansk
Country
Ukraine
Facility Name
793
City
Odessa
Country
Ukraine
Facility Name
796
City
Vinnytsya
Country
Ukraine
Facility Name
677
City
Birmingham
Country
United Kingdom
Facility Name
178
City
Brighton
Country
United Kingdom
Facility Name
182
City
Doncaster
Country
United Kingdom
Facility Name
179
City
Leeds
Country
United Kingdom
Facility Name
181
City
Romford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

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