AN EXTENSION STUDY TO EVALUATE THE SUSTAINABILITY OF CLINICALBENEFITS, SAFETY AND TOLERABILITY OF SECUKINUMAB IN PATIENTSWITH ACTIVE ANKYLOSING SPONDYLITIS

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 34 人开始时间: 2014年5月16日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Written informed consent must be obtained before any assessment is performed
•2. Subjects must have completed the core study
•3. Subjects who are deemed by the investigator to benefit from continued secukinumab

•1. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
•2. Any subject who is deemed not to be benefiting from the study drug based upon lack of
•improvement or worsening of their symptoms
•3. Use of any investigational drug except for secukinumab during the core study
•4. Any subject taking other concomitant biologic immunomodulating agent(s) except
•secukinumab during the core study
•5. 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.
•6. Women of child-bearing potential, defined as all women physiologically capable of
•becoming pregnant, unless they are using effective methods of contraception during
•dosing of study treatment and for 16 weeks after stopping treatment. Effective
•contraception methods include:

发起方

OVARTIS BIOSCIENSES PERU S.A.,