CTRI/2012/05/002688Not yet recruitingPhase 2
An Open-label Long-term Safety Extension Trial for Subjects with Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Anthera Pharmaceuticals Inc
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Completed the treatment period specified in study AN-SLE3321
Exclusion Criteria
- •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.
- •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.
Investigators
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