NCT03037489已完成2 期
An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis
Medivir3 个研究点 分布在 3 个国家目标入组 50 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
研究概览
简要总结
This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).
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
- 40 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by
- •Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by
- •Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2
排除标准
- •The presence of any inflammatory arthritis
- •Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
- •Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
- •Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
研究组 & 干预措施
MIV-711
Experimental
MIV-711 for a total of 26 weeks
干预措施: MIV-711 (Drug)
结局指标
主要结局
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
时间窗: Group A: 0-56 weeks; Group B: 0-30 weeks
1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) 2. Number of Participants with Serious Adverse Events (SAEs) 3. Number of Participants with TEAEs related to treatment 4. Number of Participants with mild TEAEs 5. Number of Participants with moderate TEAEs 6. Number of Participants with severe TEAEs 7. Number of Participants with TEAEs leading to early discontinuation
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
终止
3 期
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusLupus Erythematosus, SystemicNCT00381810Genentech, Inc.31
终止
2 期
Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie Tooth (CMT) Disease Types 1 and X (CMT1 and CMTX)Facioscapulohumeral Muscular DystrophyCharcot-Marie-Tooth DiseaseNCT03943290Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA62
终止
2 期
Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)Leukemia, Myeloid, AcuteNCT00129948SGX Pharmaceuticals, Inc.211
已完成
2 期
Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCLDiffuse Large B-cell LymphomaNCT02399085MorphoSys AG81
招募中
2 期
Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCLDLBCLNCT05552937Beijing InnoCare Pharma Tech Co., Ltd.50