None listed
Conditions
Interventions
Group 1 Type of group
1 mg/kg dose of belimumab given IV every 28 days.
Group name:Group 2 Type of group
10 mg/kg dose of belimumab given IV every 28 days.
Sponsors
HUMAN GENOME SCIENCES, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Completed Protocols HGS1006-C1056 or HGS1006-C1057 until Week 72 or 48 visits, respectively. • Be able to receive the first dose of belimumab from HGS1006-C1074 for four weeks (minimum two weeks, maximum 8 weeks) after the last dose of HGS1006-C1056 or HGS1006-C1057. • A female subject is eligible to enter the study if: Not pregnant or breastfeeding; She is not of childbearing age (that is, women with a history of hysterectomy, with menopause defined as amenorrhea of ​​1 year, with bilateral ovariectomy or with documented tubal ligation); She is of childbearing age (that is, women with functional ovaries and without documented oviductal or uterine function impairment that could lead to sterility). This category includes women with oligomenorrhea [even severe], perimenopausal women or who just started menstruating. These women must have a negative pregnancy test on Day 0, • A male subject is eligible to enter the study if they agree to use a contraceptive method during the study and for 3 months after the last dose of the study medication. • Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of health information related to the research) and adhere to the study protocol procedures (including required study visits) .
Exclusion criteria
Exclusion criteria: Have clinical evidence of significantly unstable or uncontrolled acute or chronic diseases not due to SLE (that is, cardiovascular, pulmonary, hematological, gastrointestinal, hepatic, renal, neurological, infectious or oncological diseases) or experienced an adverse event (AE) in the Phase 3 study that, in the opinion of the principal investigator, could confuse the results of the study or put the subject at undue risk. • Having a scheduled surgical procedure or history of any other medical illness (eg, cardiopulmonary), laboratory abnormality, or condition (eg, poor venous access) that, in the opinion of the principal investigator, makes the subject inadequate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized. Measure:Number of Participants With Adverse Events (AE) Timepoints:Up to 9 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study. Measure:AE Rates by System Organ Class (SOC) During the Study Timepoints:Up to 9 years ; Outcome name:An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized. Measure:Number of Participants With Serious Adverse Events (SAE) Timepoints:Up to 9 years ; Outcome name:SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study. Measure:SAE Rates by SOC During the Study Timepoints:Up to 9 years ; Outcome name:Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-u | — |
Countries
Austria, Brazil, Canada, Chile, Colombia, France, Honduras, India, Israel, Italy, Korea South, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, United Kindgdom
Contacts
Public ContactMary Talledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed