Safety and efficacy of Tofacitinib in osteoarthrtis knee: a randomized placebo-controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy (pain relief, VAS) of Tofacitinib in OA knee patients compared to placebo
研究概览
简要总结
Osteoarthritis (OA) is a problem of the elderly, affecting more than 300 million people worldwide. It is mainly a degenerative process affecting the cartilage of large weight-bearing joints. The knee joint is the most common joint to be affected by primary OA. It is one of the leading causes of disability and morbidity among adults, leading to pain and limitation of range of motion, which in turn affects the quality of life. Due to better health care services, the life expectancy is increasing. As a result of this, the geriatric problems are becoming more common. OA is a mechanical problem arising due to the degradation of cartilage, which in turn leads to skeletal deformities and further leads to cartilage damage. This vicious cycle continues, rendering the joint severely damaged and needing surgical intervention. This damage can be arrested by use of agents that impair this premature breakdown of the cartilage
Tofacitinib is a JAK-Stat pathway inhibitor that inhibits cartilage matrix degradation and prolongs the life of chondrocytes. It also has an anti-inflammatory action. These effects are mainly studied using in vitro models. This drug is well-studied in patients with rheumatoid arthritis and ankylosing spondylitis. But no such study has taken place in human subjects. We wish to conduct this study to look for the efficacy of Tofacitinib in OA knee patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients diagnosed with OA knee, Kellgren-Lawrence grade 1 and 2
- •Age more than 50 years
- •Patients willing to participate.
排除标准
- •Patients allergic to Tofacitinib
- •Patients on immunosuppressants
- •Patients with inflammatory arthritis
- •Patients with OA knee (Kellgren-Lawrence grade 3 and 4)
- •Patients with skin infections.
结局指标
主要结局
1. To evaluate the efficacy (pain relief, VAS) of Tofacitinib in OA knee patients compared to placebo
时间窗: 1,2,3,6 months
次要结局
- 1. Functional outcome (WOMAC/OKS)(2. HRQOL using EQ5D-5L)
研究者
Dr Sujit Kumar Tripathy
AIIMS Bhubaneswar
