An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing Spondylitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 15
- 主要终点
- Number of Participants Reported Adverse Events (AE's)
研究概览
简要总结
This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 took part and completed in the core CAIN457A2209 study
- •Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later could enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they fulfilled either one of the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were required to come for an additional baseline visit (Visit 17) and were required to fulfill either one of the criteria below:
- •No improvement (compared with the core study baseline) in two out of the following four domains: patient global assessment, pain, BASFI and the mean of the two morning stiffness questions from the BASDAI. OR
- •Deterioration (compared with the core study baseline) in one of the four domains (deterioration defined as >=20% worsening and an absolute worsening of >=1 unit)
排除标准
- •Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
- •Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.
- •Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study
- •Pregnant or lactating women
- •Presence of active infection
- •Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN457
干预措施: AIN457A (Biological)
结局指标
主要结局
Number of Participants Reported Adverse Events (AE's)
时间窗: From start of the study up to 64 weeks
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
次要结局
- Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)(At end of infusion (Week 64))
- Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)(Pre-dose (Week 0))
- Number of Participants Reported Positive Antibodies for Secukinumab(Pre-dose, Week 0, 8, 24, 40 and Week 64)
- Total Interleukin (IL)- 17A Concentration in Blood at Steady-State(Pre-dose and at the end of infusion (up to 64 weeks))