A multicenter extension trial of subcutaneously administered AIN457 in patients with moderate to severe chronic plaque-type psoriasis

ovartis Pharma Services AG0 个研究点目标入组 275 人开始时间: 2010年4月8日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4).
•- Patients must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
•- Patients must be expected to benefit from ongoing treatment with AIN457, as assessed by the patient and the investigator.
•- Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration.
•Reliable contraception is defined as using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants (by the partner), injectables, combined oral contraceptives (by the partner), and some intrauterine devices (by the partner); Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable.
•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 who experience a second consecutive full relapse at visit 13 (week F4) of the core study CAIN457A2211
•- 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 (> 5 mIU/mL)
•- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:
•? women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
•? women whose partners have been sterilized by vasectomy or other means
•? using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, condoms (by the partner) and some intrauterine devices (IUDs); Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable

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