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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY1)

Primary Purpose

Systemic Lupus Erythematosus

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

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  • 177
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  • 325
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  • 328
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  • 330
  • 178
  • 182
  • 179
  • 181

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. 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. 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. 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. 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
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 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.

Full Information

First Posted
December 14, 2010
Last Updated
August 31, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01262365
Brief Title
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
Acronym
EMBODY1
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
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 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
793 (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)
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo infusions delivered weekly for 4 weeks 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. 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. 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. 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. 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
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.
Time Frame
At Week 24
Title
Change From Baseline in Daily Corticosteroid Dose at Week 48
Description
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.
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 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
069
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
063
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
085
City
Escondido
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
074
City
San Diego
State/Province
California
Country
United States
Facility Name
80
City
San Gabriel
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
039
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
042
City
Aventura
State/Province
Florida
Country
United States
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090
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
092
City
DeBary
State/Province
Florida
Country
United States
Facility Name
064
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
082
City
Miami
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
062
City
Tamarac
State/Province
Florida
Country
United States
Facility Name
050
City
Tampa
State/Province
Florida
Country
United States
Facility Name
087
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
044
City
Lawrenceville
State/Province
Georgia
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
040
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
047
City
Saint Clair Shores
State/Province
Michigan
Country
United States
Facility Name
067
City
Las Cruces
State/Province
New Mexico
Country
United States
Facility Name
053
City
New York
State/Province
New York
Country
United States
Facility Name
077
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
058
City
Durham
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
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
099
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
001
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
034
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
057
City
Memphis
State/Province
Tennessee
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
079
City
Dallas
State/Province
Texas
Country
United States
Facility Name
055
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
426
City
Maroochydore
State/Province
Queensland
Country
Australia
Facility Name
425
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
429
City
Camperdown
Country
Australia
Facility Name
427
City
Clayton
Country
Australia
Facility Name
430
City
Liverpool
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
455
City
Campinas
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
452
City
Salvador
Country
Brazil
Facility Name
454
City
Sao Paulo
Country
Brazil
Facility Name
201
City
Plovdiv
Country
Bulgaria
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
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
Country
France
Facility Name
114
City
Nantes
Country
France
Facility Name
112
City
Paris
Country
France
Facility Name
116
City
Pessac
Country
France
Facility Name
127
City
Berlin
Country
Germany
Facility Name
128
City
Frankfurt
Country
Germany
Facility Name
126
City
Freiburg
Country
Germany
Facility Name
130
City
Hannover
Country
Germany
Facility Name
129
City
Plochingen
Country
Germany
Facility Name
351
City
Bangalore
Country
India
Facility Name
352
City
Hyderabad
Country
India
Facility Name
350
City
Lucknow
Country
India
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
148
City
Padova
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
309
City
Daegu
Country
Korea, Republic of
Facility Name
308
City
Daejeon
Country
Korea, Republic of
Facility Name
304
City
Incheon
Country
Korea, Republic of
Facility Name
310
City
Jeonju
Country
Korea, Republic of
Facility Name
301
City
Junggu
Country
Korea, Republic of
Facility Name
307
City
Seoul
Country
Korea, Republic of
Facility Name
302
City
Suwon
Country
Korea, Republic of
Facility Name
155
City
Kaunas
Country
Lithuania
Facility Name
156
City
Klaipeda
Country
Lithuania
Facility Name
475
City
Guadalajara
Country
Mexico
Facility Name
476
City
Guadalajara
Country
Mexico
Facility Name
478
City
Guadalajara
Country
Mexico
Facility Name
480
City
Mérida
Country
Mexico
Facility Name
091
City
Cidra
Country
Puerto Rico
Facility Name
086
City
San Juan
Country
Puerto Rico
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
261
City
Cluj-Napoca
Country
Romania
Facility Name
281
City
Ekaterinburg
Country
Russian Federation
Facility Name
285
City
Petrozavodsk
Country
Russian Federation
Facility Name
284
City
Saint Petersburg
Country
Russian Federation
Facility Name
165
City
La Laguna
State/Province
Santa Cruz De Tenerife
Country
Spain
Facility Name
164
City
Bilbao
State/Province
Vizcaya
Country
Spain
Facility Name
161
City
Barcelona
Country
Spain
Facility Name
162
City
Madrid
Country
Spain
Facility Name
163
City
Madrid
Country
Spain
Facility Name
166
City
Malaga
Country
Spain
Facility Name
177
City
Santander
Country
Spain
Facility Name
160
City
Sevilla
Country
Spain
Facility Name
325
City
Changhua
Country
Taiwan
Facility Name
326
City
Chiayi City
Country
Taiwan
Facility Name
328
City
Kaohsiung
Country
Taiwan
Facility Name
329
City
Taichung
Country
Taiwan
Facility Name
330
City
Taipei
Country
Taiwan
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

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

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