Safety Extension Trial for Subjects with Systemic Lupus Erythematosus.
- Conditions
- Health Condition 1: null- SLE
- Registration Number
- CTRI/2012/05/002688
- Lead Sponsor
- Anthera Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Completed the treatment period specified in study AN-SLE3321
1.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.
a)This includes active significant infection, malignancy, and acutely life or organ-threatening manifestation of SLE (e.g., proliferative nephritis or unstable CNS lupus).
2.Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline (if the subject is a female of childbearing potential). Males who are intending to impregnate a female. All sexually-active subjects of reproductive potential are required to use a reliable method of birth control during the study and for 3 months following completion of therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom) or vasectomy.
3. Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
a)Cyclophosphamide or other alkylating agent â?? 3 months prior to screening
b)Cyclosporine â?? 2 months prior to screening
c)Anti-TNF alpha â?? 3 months prior to screening
d)Transfusion, IV immunoglobulin, plasmapheresis or plasma exchange â?? 3 months prior to screening
e)Live vaccines â?? 30 days prior to screening
4.Any prior administration of a B-cell modulating therapy (i.e., belimumab, TACI-Ig, epratuzumab, rituximab) other than A-623.
5.General
a) Subject has known sensitivity to any of the products to be administered during dosing.
b) Subject will not be available for follow-up assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -The primary objective of the study is to assess the safety of A-623 following long-term <br/ ><br>administration.Timepoint: long-term treatment i.e 52 weeks
- Secondary Outcome Measures
Name Time Method o secondary objective in the studyTimepoint: None