Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Lupus, Lupus Erythematosus, Systemic, A-623, Autoimmune Diseases, Blisibimod
Brief summary
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
Interventions
DRUGA-623
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Sponsors
Anthera Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Argentina, Brazil, Chile, Colombia, Hong Kong, India, Mexico, Peru, Philippines, Taiwan, United States
Outcome results
None listed