AN OPEN-LABEL LONG-TERM SAFETY EXTENSION TRIAL FOR SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS WHO HAVE COMPLETED PROTOCOL AN-SLE3321 (PEARL-SC).

Anthera Pharmaceuticals, Inc.,0 个研究点目标入组 41 人开始时间: 2012年3月14日最近更新: 2023年9月4日

试验速览

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•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

发起方

Anthera Pharmaceuticals, Inc.,