A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2

ovartis Pharma Services AG0 个研究点开始时间: 2009年2月20日最近更新: 2014年10月7日

研究概览

暂无简介。

•Patients who completed the extension 1 study may enter the extension 2 study upon
•signing informed consent.
•A patient is defined as completing the extension 1 study if he/she completed the study up to and including Visit 31.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients for whom continuation of treatment in the extension 2 is not considered
•appropriate by the treating physician.
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
•female after conception and until the termination of gestation confirmed by a positive
•hCG laboratory test (>5mIU/mL).
•Women of childbearing potential (WOCBP) defined as all women physiologically capable of becoming pregnant, UNLESS they are: • Using a double barrier method of contraception such as intrauterine devices (IUDs), oral contraceptives, sub-dermal implants and a barrier method with spermicide, condoms. • Women whose partners have been sterilized by vasectomy or other means. • Considered post-menopausal and not of childbearing potential if they have had 24 months of natural (spontaneous) amenorrhea or six months of spontaneous amenorrhea with serum
•FSH levels > 40 mIU/mL (for US only estradiol < 20 pg/mL) or have had surgical
•bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
•Note: FSH and estradiol tests do not need to be performed for surgically sterile or women on estrogen replacement therapy. Females of childbearing potential must agree to continue to practice an acceptable form of birth control during the trial and for at least 2 months after completing the trial.

发起方