NCT03412864Unknown不适用
Post Marketing Surveillance on Safety and Effectiveness Evaluation of INVOSSA K Inj.
Kolon Life Science1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年7月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- AEs (Adverse Events)
研究概览
简要总结
This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients over 19 years
- •Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria :
- •Moderate knee osteoarthritis (Kellgren & Lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months
- •Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form
排除标准
- •Pregnant or breastfeeding female
- •Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
- •Patients who have severe disease such as heart, liver, kidney disease or other severe complications
- •Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
- •Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins)
- •Patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months
- •Patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of INVOSSA-K inj. or patients with a history thereof
- •Patients with Kellgran & Lawrence grade 4 osteoarthritis
结局指标
主要结局
AEs (Adverse Events)
时间窗: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Changes of incidence rate in AEs
次要结局
- 100 mm VAS (Visual Analog Scale)(0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3))
- Physical examination (Knee joint swelling)(0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3))
- Physical examination (Tenderness)(0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3))
- Physical examination (ROM)(0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3))
- General efficacy evaluation(6 Months(visit 3))
研究者
研究点 (1)
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