CTRI/2014/04/004518Other3 期
A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents
Novartis Healthcare Pvt Ltd6 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2014年2月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 242
- 试验地点
- 6
- 主要终点
- To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to
研究概览
简要总结
A phase 3 trial to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents.
Planned no. of patients from India: 25
FPFV achived on 27 Feb 2014 from India
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject 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
- •Male or non-pregnant, non-lactating female subjects at least 18 years of age
- •Presence of RA classified by ACR 2010 revised criteria (see Appendix 2) for at least 3 months before screening • At Baseline: Disease activity criteria defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 WITH at least 1 of the following at screening:.
- •Anti-CCP antibodies positive OR.
- •Rheumatoid Factor positive AND WITH at least 1 of the following at screening:.
- •hsCRP ≥ 10 mg/L OR.
- •ESR ≥28 mm/1st hr
- •Subjects must have been taking at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent.
排除标准
- •Chest x-ray or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- •RA subjects functional status class IV according to the ACR 1991 revised criteria (see Appendix 3)
- •Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- •Use of any investigational drug and/or devices within 4 weeks before randomization, or a period of 5 half-lives of the investigational drug, whichever is longer.
结局指标
主要结局
To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to
时间窗: 52 weeks
response.
时间窗: 52 weeks
placebo in patients with active RA based on the proportion of patients achieving an ACR20
时间窗: 52 weeks
次要结局
- To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior(to placebo in patients with active RA based on the proportion of subjects achieving an)
- To demonstrate the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to(placebo with respect to the improvement (change) from baseline in HAQ-DI)
研究者
研究点 (6)
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