The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,250
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
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.
Time frame: During the treatment period (through Week 96)
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
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.
Time frame: During the treatment period (through Week 96)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
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
Time frame: During the treatment period (through Week 96)
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
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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539
Birmingham, Alabama, United States
557
Little Rock, Arkansas, United States
515
Hemet, California, United States
544
Huntington Beach, California, United States
550
La Jolla, California, United States
031
Los Angeles, California, United States
051
Los Angeles, California, United States
089
Los Angeles, California, United States
531
San Leandro, California, United States
594
Thousand Oaks, California, United States
...and 218 more locations
Time frame: During the treatment period (through Week 96)
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Time frame: At Week 48
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Time frame: Week 48
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Time frame: Week 96
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Time frame: Week 96