A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B TM), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057.
- Conditions
- -L93L93
- Registration Number
- PER-098-08
- Lead Sponsor
- HUMAN GENOME SCIENCES, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 26
• 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) .
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Number of Participants With Adverse Events (AE)<br>Timepoints:Up to 9 years<br>
- Secondary Outcome Measures
Name Time Method