Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01262365
Registration number
NCT01262365
Ethics application status
Date submitted
14/12/2010
Date registered
17/12/2010
Date last updated
28/09/2018
Titles & IDs
Public title
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2010-018563-41
Query!
Secondary ID [2]
0
0
SL0009
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EMBODY1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Epratuzumab
Treatment: Drugs - Epratuzumab
Treatment: Drugs - Placebo
Placebo comparator: Placebo (Weekly infusion) - Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Experimental: Epratuzumab 600 mg per week - 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Experimental: Epratuzumab 1200 mg every other week - 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
Treatment: Drugs: Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Treatment: Drugs: Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Treatment: Drugs: Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
At Week 48
Query!
Secondary outcome [1]
0
0
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
At Week 24
Query!
Secondary outcome [2]
0
0
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
At Week 12
Query!
Secondary outcome [3]
0
0
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
At Week 36
Query!
Secondary outcome [4]
0
0
Change From Baseline in Daily Corticosteroid Dose at Week 24
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
At Week 24
Query!
Secondary outcome [5]
0
0
Change From Baseline in Daily Corticosteroid Dose at Week 48
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
At Week 48
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
793
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
426 - Maroochydore
Query!
Recruitment hospital [2]
0
0
425 - Malvern
Query!
Recruitment hospital [3]
0
0
429 - Camperdown
Query!
Recruitment hospital [4]
0
0
427 - Clayton
Query!
Recruitment hospital [5]
0
0
430 - Liverpool
Query!
Recruitment postcode(s) [1]
0
0
- Maroochydore
Query!
Recruitment postcode(s) [2]
0
0
- Malvern
Query!
Recruitment postcode(s) [3]
0
0
- Camperdown
Query!
Recruitment postcode(s) [4]
0
0
- Clayton
Query!
Recruitment postcode(s) [5]
0
0
- Liverpool
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Mexico
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oklahoma
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Brussels
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Leuven
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Liege
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Campinas
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Porto Alegre
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Recife
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Rio de Janeiro
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Salvador
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Sao Paulo
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Plovdiv
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Sofia
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Olomouc
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Praha 2
Query!
Country [35]
0
0
Czechia
Query!
State/province [35]
0
0
Zlin
Query!
Country [36]
0
0
Estonia
Query!
State/province [36]
0
0
Tallinn
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Lille
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Nantes
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Paris
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Pessac
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Berlin
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Frankfurt
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Freiburg
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Hannover
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Plochingen
Query!
Country [46]
0
0
India
Query!
State/province [46]
0
0
Bangalore
Query!
Country [47]
0
0
India
Query!
State/province [47]
0
0
Hyderabad
Query!
Country [48]
0
0
India
Query!
State/province [48]
0
0
Lucknow
Query!
Country [49]
0
0
Israel
Query!
State/province [49]
0
0
Ashkelon
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Beer Sheva
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Haifa
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Jerusalem
Query!
Country [53]
0
0
Israel
Query!
State/province [53]
0
0
Kfar Saba
Query!
Country [54]
0
0
Israel
Query!
State/province [54]
0
0
Rehovot
Query!
Country [55]
0
0
Israel
Query!
State/province [55]
0
0
Tel Aviv
Query!
Country [56]
0
0
Israel
Query!
State/province [56]
0
0
Tel-Hashomer
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Ferrara
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Padova
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Torino
Query!
Country [60]
0
0
Korea, Republic of
Query!
State/province [60]
0
0
Busan
Query!
Country [61]
0
0
Korea, Republic of
Query!
State/province [61]
0
0
Daegu
Query!
Country [62]
0
0
Korea, Republic of
Query!
State/province [62]
0
0
Daejeon
Query!
Country [63]
0
0
Korea, Republic of
Query!
State/province [63]
0
0
Incheon
Query!
Country [64]
0
0
Korea, Republic of
Query!
State/province [64]
0
0
Jeonju
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Junggu
Query!
Country [66]
0
0
Korea, Republic of
Query!
State/province [66]
0
0
Seoul
Query!
Country [67]
0
0
Korea, Republic of
Query!
State/province [67]
0
0
Suwon
Query!
Country [68]
0
0
Lithuania
Query!
State/province [68]
0
0
Kaunas
Query!
Country [69]
0
0
Lithuania
Query!
State/province [69]
0
0
Klaipeda
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
Guadalajara
Query!
Country [71]
0
0
Mexico
Query!
State/province [71]
0
0
Mérida
Query!
Country [72]
0
0
Puerto Rico
Query!
State/province [72]
0
0
Cidra
Query!
Country [73]
0
0
Puerto Rico
Query!
State/province [73]
0
0
San Juan
Query!
Country [74]
0
0
Romania
Query!
State/province [74]
0
0
Brasov
Query!
Country [75]
0
0
Romania
Query!
State/province [75]
0
0
Bucharest
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Cluj-Napoca
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Ekaterinburg
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Petrozavodsk
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Saint Petersburg
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Santa Cruz De Tenerife
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Vizcaya
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Barcelona
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Madrid
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Malaga
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Santander
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Sevilla
Query!
Country [87]
0
0
Taiwan
Query!
State/province [87]
0
0
Changhua
Query!
Country [88]
0
0
Taiwan
Query!
State/province [88]
0
0
Chiayi City
Query!
Country [89]
0
0
Taiwan
Query!
State/province [89]
0
0
Kaohsiung
Query!
Country [90]
0
0
Taiwan
Query!
State/province [90]
0
0
Taichung
Query!
Country [91]
0
0
Taiwan
Query!
State/province [91]
0
0
Taipei
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Brighton
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Doncaster
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Leeds
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Romford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
UCB Pharma
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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)
Query!
Trial website
https://clinicaltrials.gov/study/NCT01262365
Query!
Trial related presentations / publications
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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCb Clinical Trial Call Center
Query!
Address
0
0
+1 877 822 9493 (UCB)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01262365
Download to PDF