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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
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Scientific title
A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
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Secondary ID [1]
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0
2010-020859-30
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Secondary ID [2]
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SL0012
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Universal Trial Number (UTN)
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Trial acronym
EMBODY4
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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0
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
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Assessment method [1]
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A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
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Timepoint [1]
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During the treatment period (through Week 96)
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Primary outcome [2]
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Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
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Assessment method [2]
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A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
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Timepoint [2]
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During the treatment period (through Week 96)
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Primary outcome [3]
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Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
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Assessment method [3]
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A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:
* Death
* Life-threatening
* Significant or persistent disability/incapacity
* Congenital anomaly/birth defect (including that occurring in a fetus)
* Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
* Initial inpatient hospitalization or prolongation of hospitalization
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Timepoint [3]
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During the treatment period (through Week 96)
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Primary outcome [4]
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Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
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Assessment method [4]
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A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:
* Death
* Life-threatening
* Significant or persistent disability/incapacity
* Congenital anomaly/birth defect (including that occurring in a fetus)
* Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
* Initial inpatient hospitalization or prolongation of hospitalization
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Timepoint [4]
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0
During the treatment period (through Week 96)
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Secondary outcome [1]
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Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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Assessment method [1]
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Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
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Timepoint [1]
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At Week 48
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Secondary outcome [2]
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Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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Assessment method [2]
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0
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
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Timepoint [2]
0
0
Week 48
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Secondary outcome [3]
0
0
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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Assessment method [3]
0
0
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
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Timepoint [3]
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Week 96
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Secondary outcome [4]
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The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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Assessment method [4]
0
0
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
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Timepoint [4]
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Week 96
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2016
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Sample size
Target
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Accrual to date
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Final
1250
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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429 - Camperdown
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Recruitment hospital [2]
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427 - Clayton
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Recruitment hospital [3]
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430 - Liverpool
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Recruitment hospital [4]
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425 - Malvern
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Recruitment hospital [5]
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426 - Maroochydore
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Recruitment postcode(s) [1]
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- Camperdown
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Recruitment postcode(s) [2]
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- Clayton
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Recruitment postcode(s) [3]
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- Liverpool
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Recruitment postcode(s) [4]
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- Malvern
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Recruitment postcode(s) [5]
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- Maroochydore
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Alabama
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0
United States of America
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State/province [2]
0
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Arkansas
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0
0
United States of America
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State/province [3]
0
0
California
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0
0
United States of America
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State/province [4]
0
0
Colorado
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0
0
United States of America
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State/province [5]
0
0
Connecticut
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0
0
United States of America
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0
0
Florida
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0
0
United States of America
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State/province [7]
0
0
Georgia
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0
0
United States of America
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0
0
Idaho
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0
0
United States of America
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0
0
Illinois
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0
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United States of America
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Indiana
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0
0
United States of America
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0
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Louisiana
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0
0
United States of America
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0
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Michigan
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0
0
United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Country [26]
0
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Belgium
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Brussels
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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State/province [29]
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Belo Horizonte
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Brazil
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State/province [30]
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Campinas
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Brazil
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Goiânia
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Brazil
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Juiz de Fora
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Bulgaria
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Sofia
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Canada
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Ontario
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Canada
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Hamilton
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Canada
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Mississauga
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Canada
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Rimouski
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Canada
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St. John's
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Canada
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Toronto
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Czechia
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Olomouc
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Czechia
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Praha 2
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Czechia
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Zlin
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Estonia
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Tallinn
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France
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Lille Cedex
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France
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Limoges Cedex
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France
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State/province [51]
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Montpellier Cedex 5
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France
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Paris
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0
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France
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State/province [53]
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Pessac
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0
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France
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State/province [54]
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Toulouse Cedex 9
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0
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Germany
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0
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Berlin
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0
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Germany
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0
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Frankfurt
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0
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Germany
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Freiburg
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0
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Germany
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Hamburg
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0
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Germany
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State/province [59]
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Herne
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0
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Germany
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Koln
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0
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Germany
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Leipzig
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Germany
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Mainz
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0
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Germany
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Munster
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0
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Germany
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Plochingen
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0
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Germany
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State/province [65]
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Roßlau
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0
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Germany
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Zerbst
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0
0
Hong Kong
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Shatin
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0
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Hungary
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Budapest
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0
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Hungary
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Debrecen
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Hungary
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Szeged
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0
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Hungary
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Zalaegerszeg
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0
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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0
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Israel
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Jerusalem
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0
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Israel
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Kfar Saba
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0
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Israel
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Rehovot
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Israel
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Tel Aviv
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0
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Israel
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Tel-Hashomer
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Italy
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Ferrara
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Italy
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Milano
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Italy
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Padova
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0
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Italy
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0
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Pisa
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0
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Italy
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Roma
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0
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Italy
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State/province [85]
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Torino
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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Mexico City
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Mexico
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Torreon
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Poland
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Bydgoszcz
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Poland
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Czestochowa
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Poland
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Elblag
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Poland
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Katowice
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Ustron
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Poland
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Warsaw
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Constanta
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Country [112]
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0
Romania
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State/province [112]
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0
Galati
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Country [113]
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Romania
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State/province [113]
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Iasi
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Country [114]
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Russian Federation
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State/province [114]
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0
Ekaterinburg
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Country [115]
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Russian Federation
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State/province [115]
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Moscow
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Country [116]
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Russian Federation
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State/province [116]
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Petrozavodsk
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Country [117]
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Russian Federation
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State/province [117]
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Saint Petersburg
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Country [118]
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South Africa
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State/province [118]
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Cape Town
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Country [119]
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South Africa
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State/province [119]
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Durban
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Country [120]
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South Africa
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State/province [120]
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Stellenbosch
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Country [121]
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Spain
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State/province [121]
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Barcelona
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Country [122]
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Spain
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State/province [122]
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Bilbao
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Country [123]
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Spain
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Getafe
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Country [124]
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Spain
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State/province [124]
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La Laguna
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Country [125]
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Spain
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State/province [125]
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Las Palmas de Gran Canaria
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Country [126]
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Spain
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State/province [126]
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Madrid
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Country [127]
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Spain
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State/province [127]
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Malaga
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Country [128]
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Spain
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State/province [128]
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Santander
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Country [129]
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Spain
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State/province [129]
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Santiago de Compostela
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Country [130]
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Spain
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State/province [130]
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Sevilla
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Country [131]
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Spain
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State/province [131]
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Vigo
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Country [132]
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Taiwan
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State/province [132]
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Changhua
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Country [133]
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Taiwan
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State/province [133]
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Chiayi City
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Country [134]
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Taiwan
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State/province [134]
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Kaohsiung City
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Country [135]
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Taiwan
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Taipei
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Country [136]
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Ukraine
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State/province [136]
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Donetsk
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Country [137]
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Ukraine
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State/province [137]
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Ivano-Frankivsk
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Country [138]
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Ukraine
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State/province [138]
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Kiev
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Country [139]
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Ukraine
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State/province [139]
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Lugansk
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Country [140]
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Ukraine
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State/province [140]
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Odessa
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Country [141]
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Ukraine
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State/province [141]
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Vinnytsya
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Country [142]
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United Kingdom
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State/province [142]
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Birmingham
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Country [143]
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United Kingdom
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State/province [143]
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Brighton
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Country [144]
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United Kingdom
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State/province [144]
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Doncaster
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Country [145]
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United Kingdom
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State/province [145]
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0
Leeds
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Country [146]
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United Kingdom
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Romford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Pharma
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Address
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Country
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Ethics approval
Ethics application status
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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)
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Trial website
https://clinicaltrials.gov/study/NCT01408576
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Public notes
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Contacts
Principal investigator
Name
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UCB Clinical Trial Call Center
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Address
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UCB Pharma
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Email
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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/NCT01408576
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