A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
- Registration Number
- NCT01305746
- Lead Sponsor
- Anthera Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 382
- Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010
- Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
- Pregnant or nursing
- Any prior administration of a B-cell modulating therapy other than A-623
- Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A-623 high dose weekly A-623 High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study A-623 low dose weekly A-623 Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study A-623 high dose every 4 weeks A-623 High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
- Primary Outcome Measures
Name Time Method To assess the long term safety of A-623 in subjects with SLE Until the drug is approved or the Sponsor discontinues the study Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Investigator Site 103
🇺🇸Birmingham, Alabama, United States
Investigator Site 113
🇺🇸Long Beach, California, United States
Investigator Site 110
🇺🇸Upland, California, United States
Investigator Site 105
🇺🇸Orlando, Florida, United States
Investigator Site 102
🇺🇸Tampa, Florida, United States
Investigator Site 117
🇺🇸Baltimore, Maryland, United States
Investigator Site 104
🇺🇸Lansing, Michigan, United States
Investigator Site 106
🇺🇸Lake Success, New York, United States
Investigator Site 114
🇺🇸Smithtown, New York, United States
Investigator Site 101
🇺🇸Greenville, North Carolina, United States
Scroll for more (61 remaining)Investigator Site 103🇺🇸Birmingham, Alabama, United States