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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2010-018563-41
Secondary ID [2] 0 0
SL0009
Universal Trial Number (UTN)
Trial acronym
EMBODY1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
At Week 48
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
At Week 24
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
At Week 36
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
At Week 24
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
At Week 48

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
426 - Maroochydore
Recruitment hospital [2] 0 0
425 - Malvern
Recruitment hospital [3] 0 0
429 - Camperdown
Recruitment hospital [4] 0 0
427 - Clayton
Recruitment hospital [5] 0 0
430 - Liverpool
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment postcode(s) [2] 0 0
- Malvern
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Arkansas
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California
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Colorado
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Indiana
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Louisiana
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Maryland
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Michigan
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Recife
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Zlin
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Tallinn
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Chiayi City
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Taipei
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United Kingdom
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Brighton
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Doncaster
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Leeds
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United Kingdom
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Romford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/show/NCT01262365
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCb Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications