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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01408576




Registration number
NCT01408576
Ethics application status
Date submitted
1/08/2011
Date registered
3/08/2011
Date last updated
3/10/2018

Titles & IDs
Public title
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
Scientific title
A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
Secondary ID [1] 0 0
2010-020859-30
Secondary ID [2] 0 0
SL0012
Universal Trial Number (UTN)
Trial acronym
EMBODY4
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

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


Treatment: Drugs: Epratuzumab
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 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 eight 12 week treatment cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Timepoint [1] 0 0
During the treatment period (through Week 96)
Primary outcome [2] 0 0
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Timepoint [2] 0 0
During the treatment period (through Week 96)
Primary outcome [3] 0 0
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Timepoint [3] 0 0
During the treatment period (through Week 96)
Primary outcome [4] 0 0
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Timepoint [4] 0 0
During the treatment period (through Week 96)
Secondary outcome [1] 0 0
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Timepoint [1] 0 0
At Week 48
Secondary outcome [2] 0 0
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Timepoint [3] 0 0
Week 96
Secondary outcome [4] 0 0
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Timepoint [4] 0 0
Week 96

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
Open (masking not used)
Who is / are masked / blinded?



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
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
1250
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
429 - Camperdown
Recruitment hospital [2] 0 0
427 - Clayton
Recruitment hospital [3] 0 0
430 - Liverpool
Recruitment hospital [4] 0 0
425 - Malvern
Recruitment hospital [5] 0 0
426 - Maroochydore
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Maroochydore
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Illinois
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Indiana
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Louisiana
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Michigan
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Missouri
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Hamilton
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Roßlau
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Vigo
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Chiayi City
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Kaohsiung City
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Taiwan
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Taipei
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kiev
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Ukraine
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Lugansk
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Ukraine
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Odessa
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Ukraine
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Vinnytsya
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United Kingdom
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Birmingham
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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 assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
Trial website
https://clinicaltrials.gov/study/NCT01408576
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
UCB Pharma
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01408576