A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), 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
- SLESystemische Lupus Erythematosus10003816
- Registration Number
- NL-OMON39387
- Lead Sponsor
- Human Genome Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
1. Have completed the HGS1006-C1056 or HGS1006-C1057 Protocol through the week 72 or week 48 visits, respectively.
2. Be able to receive the 1st dose of belimumab for HGS1006-C1074 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in HGS1006-C1056 or HGS1006 C1057.
1. Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.;2. Have developed any other medical diseases (eg, cardiopulmonary), laboratory abnormalities, or conditions (eg, poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>As this is a follow-up study studying the long-term safety aspects of the use<br /><br>of the study medication, the only study variable is the number of adverse<br /><br>events. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As this is a follow-up study studying the long-term safety aspects of the use<br /><br>of the study medication, there are no other study variables than the number of<br /><br>adverse events. </p><br>