Evaluation of inflammatory and structural joint damage in patients with psoriasis and psoriatic arthritis treated with secukinumab: A phase 2, single arm, single centre mode of action study (Psoriasis-Arthritis & Bone Program) - PSARTROS

niversitätsklinikum Erlangen0 个研究点目标入组 40 人开始时间: 2015年3月11日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•Men and women aged 18 years and older
•Negative urine pregnancy test in females of child-bearing potential
•Adequate wash-out period for subjects previously treated with TNF-alpha inhibitors or ustekinumab
•Moderate to severe psoriatric arthritis with symptoms for at least 6 months or moderate to severe psoriasis with inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Radiological evidence of ongoing infectious or malignant process
•Intake of high potency opioids
•Previous exposure to secukinumab or other biological drugs directly targeting the IL-17 axis
•Previous cell-depleting therapies
•History of any condition which poses an unacceptable risk for receiving an immunomodulatory therapy
•History of alcohol or drug abuse within the last six months before randomization

发起方

niversitätsklinikum Erlangen