None listed
Conditions
Interventions
THE STUDY WILL BE CONDUCTED IN APPROXIMATELY 90 CENTERS WORLDWIDE.
UP TO 600 SUBJECTS WILL BE ELIGIBLE TO ENROLL INTO THE STUDY IF THEY COMPLETE THE AN-SLE3321 STUDY.
IN ORDER TO PRESERVE THE BL
Sponsors
Anthera Pharmaceuticals, Inc.,
Eligibility
Sex/Gender
All
Age
13 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. COMPLETED THE TREATMENT PERIOD SPECIFIED IN STUDY AN-SLE3321.
Exclusion criteria
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 VALUATION, COMPLETION, AND/OR PROCEDURES. • 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 URSING, 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 CHILD-BEARING POTENTIAL). MALES WHO ARE INTENDING TO IMPREGNATE A FEMALE. ALL SEXUALLY-ACTIVE SUBJCTS 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 OAM 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
Countries
Argentina, Brazil, Chile, China, Colombia, India, Mexico, Peru, Philippines, Taiwan, United States
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed