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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (EMBODY2)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
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:

  • 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 SLE disease activity index (SLEDAI) total score
  • On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

  • 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.

Sites / Locations

  • 539
  • 557
  • 515
  • 544
  • 550
  • 548
  • 589
  • 531
  • 558
  • 594
  • 532
  • 511
  • 514
  • 533
  • 518
  • 585
  • 538
  • 537
  • 587
  • 590
  • 543
  • 592
  • 576
  • 572
  • 554
  • 513
  • 599
  • 575
  • 549
  • 596
  • 593
  • 568
  • 551
  • 553
  • 545
  • 577
  • 559
  • 547
  • 561
  • 535
  • 598
  • 571
  • 574
  • 570
  • 541
  • 563
  • 562
  • 552
  • 534
  • 954
  • 956
  • 955
  • 950
  • 952
  • 506
  • 507
  • 508
  • 502
  • 500
  • 504
  • 517
  • 613
  • 618
  • 617
  • 614
  • 616
  • 628
  • 633
  • 636
  • 637
  • 632
  • 629
  • 625
  • 626
  • 634
  • 627
  • 639
  • 631
  • 712
  • 716
  • 718
  • 717
  • 711
  • 715
  • 713
  • 852
  • 853
  • 648
  • 647
  • 646
  • 978
  • 976
  • 982
  • 981
  • 743
  • 744
  • 752
  • 745
  • 746
  • 748
  • 750
  • 742
  • 747
  • 751
  • 749
  • 757
  • 758
  • 760
  • 759
  • 756
  • 761
  • 778
  • 780
  • 779
  • 901
  • 902
  • 903
  • 661
  • 660
  • 662
  • 664
  • 663
  • 659
  • 791
  • 790
  • 794
  • 797
  • 792
  • 793
  • 796
  • 677
  • 678
  • 679

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo (Weekly infusion)

Epratuzumab 600 mg per week

Epratuzumab 1200 mg every other week

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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

The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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 12 According to a Combined Response Index
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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.
Change From Baseline in Daily Corticosteroid Dose at Week 24
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.
Change From Baseline in Daily Corticosteroid Dose at Week 48
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.

Full Information

First Posted
December 14, 2010
Last Updated
November 20, 2020
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01261793
Brief Title
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
Acronym
EMBODY2
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
791 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (Weekly infusion)
Arm Type
Placebo Comparator
Arm Description
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Arm Title
Epratuzumab 600 mg per week
Arm Type
Experimental
Arm Description
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 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 four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Intervention Type
Drug
Intervention Name(s)
Epratuzumab
Intervention Description
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 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 four 12-week treatment cycles
Primary Outcome Measure Information:
Title
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Description
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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.
Time Frame
At Week 48
Secondary Outcome Measure Information:
Title
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Description
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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.
Time Frame
At Week 24
Title
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Description
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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.
Time Frame
At Week 12
Title
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Description
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). 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.
Time Frame
At Week 36
Title
Change From Baseline in Daily Corticosteroid Dose at Week 24
Description
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.
Time Frame
At Week 24
Title
Change From Baseline in Daily Corticosteroid Dose at Week 48
Description
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.
Time Frame
At Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 SLE disease activity index (SLEDAI) total score On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
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
548
City
Los Angeles
State/Province
California
Country
United States
Facility Name
589
City
San Diego
State/Province
California
Country
United States
Facility Name
531
City
San Leandro
State/Province
California
Country
United States
Facility Name
558
City
Torrance
State/Province
California
Country
United States
Facility Name
594
City
Westlake Village
State/Province
California
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
514
City
Brandon
State/Province
Florida
Country
United States
Facility Name
533
City
Fort Lauderdale
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
538
City
Tampa
State/Province
Florida
Country
United States
Facility Name
537
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
587
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
590
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
543
City
Bowling Green
State/Province
Kentucky
Country
United States
Facility Name
592
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
576
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
572
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
554
City
Ann Arbor
State/Province
Michigan
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
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
593
City
Clifton
State/Province
New Jersey
Country
United States
Facility Name
568
City
Freehold
State/Province
New Jersey
Country
United States
Facility Name
551
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
553
City
Lake Success
State/Province
New York
Country
United States
Facility Name
545
City
Manhasset
State/Province
New York
Country
United States
Facility Name
577
City
Roslyn
State/Province
New York
Country
United States
Facility Name
559
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
547
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
561
City
Wyomissing
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
574
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
570
City
Austin
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
562
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
552
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
534
City
Seattle
State/Province
Washington
Country
United States
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
952
City
Rio de Janeiro
Country
Brazil
Facility Name
506
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
507
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
508
City
Rimouski
State/Province
Quebec
Country
Canada
Facility Name
502
City
Hamilton
Country
Canada
Facility Name
500
City
London
Country
Canada
Facility Name
504
City
Toronto
Country
Canada
Facility Name
517
City
Victoria
Country
Canada
Facility Name
613
City
Caen
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
616
City
Toulouse Cedex 9
Country
France
Facility Name
628
City
Berlin
Country
Germany
Facility Name
633
City
Berlin
Country
Germany
Facility Name
636
City
Dessau
Country
Germany
Facility Name
637
City
Hamburg
Country
Germany
Facility Name
632
City
Herne
Country
Germany
Facility Name
629
City
Kiel
Country
Germany
Facility Name
625
City
Köln
Country
Germany
Facility Name
626
City
Leipzig
Country
Germany
Facility Name
634
City
Mainz
Country
Germany
Facility Name
627
City
Münster
Country
Germany
Facility Name
639
City
Wiesbaden
Country
Germany
Facility Name
631
City
Zerbst
Country
Germany
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
852
City
Ahmedabad
Country
India
Facility Name
853
City
Bangalore
Country
India
Facility Name
648
City
Milano
Country
Italy
Facility Name
647
City
Pisa
Country
Italy
Facility Name
646
City
Roma
Country
Italy
Facility Name
978
City
Cuauhtémoc
Country
Mexico
Facility Name
976
City
Mexico City
Country
Mexico
Facility Name
982
City
Mexico
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
745
City
Katowice
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
757
City
Bucharest
Country
Romania
Facility Name
758
City
Bucharest
Country
Romania
Facility Name
760
City
Bucharest
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
778
City
Kemerovo
Country
Russian Federation
Facility Name
780
City
Kemerovo
Country
Russian Federation
Facility Name
779
City
Moscow
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
661
City
Barcelona
Country
Spain
Facility Name
660
City
Getafe
Country
Spain
Facility Name
662
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
664
City
Madrid
Country
Spain
Facility Name
663
City
Santiago de Compostela
Country
Spain
Facility Name
659
City
Vigo
Country
Spain
Facility Name
791
City
Donetsk
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
Luhansk
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
678
City
Christchurch
Country
United Kingdom
Facility Name
679
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29381843
Citation
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.
Results Reference
derived
PubMed Identifier
27598855
Citation
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.
Results Reference
derived

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

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