The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients

Qilu Hospital of Shandong University1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2022年3月15日最近更新: 2023年11月18日

适应症

干预措施

试验速览

阶段: 4 期
状态: 进行中（未招募）
发起方: Qilu Hospital of Shandong University
入组人数: 100
试验地点: 1
主要终点: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.

详细描述

Biologic naïve participants will be randomly assigned in a 2:1 ratio to receive secukinumab or adalimumab for 24 weeks. Participants with a history of an inadequate response to secukinumab or adalimumab, will be treated with the alternative drug (adalimumab or secukinumab) for 24 weeks. The disease activity and index of inmunology will be evaluated at weeks 0, 12, 24 up to 96 weeks.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who meet modified New York 1984 criteria for ankylosing spondylitis；
•Age ≥18 years and ≤ 65 years；
•ASDAS ≥ 1.3；
•Concomitant drugs: use stable doses of NSAIDs alone for at least 4 weeks before the baseline period, stop other oral drugs such as methotrexate (MTX), sulfasalazine (SASP), glucocorticoids. Glucocorticoids can be injected locally after 12 weeks, NSAIDs keep stable for 12 weeks；
•Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.

排除标准

•Patients with severe infections, tumors and damage to vital organs:
•Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x10^9 / L;
•Propionate acid aminotransferase (ALT) or aspartate aminotransferase(AST) is two times higher than the upper limit of normal;
•Renal insufficiency: serum Cr ≥ 176 umol / L;
•Pregnant or nursing women (breastfeeding) ;
•Patients has a history of malignancy (cure time in less than 5 years);
•Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
•Patients with current or previous Crohn's disease;
•Patients with current ulcerative colitis requiring immunosuppressive therapy;
•Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis;
•Patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial;
•Patients who had inadequate response, intolerance or contraindication for both adalimumab and secukinumab.