跳至主要内容
临床试验/CTRI/2025/07/090567
CTRI/2025/07/090567尚未招募Unknown

Safety and efficacy of Tofacitinib in osteoarthrtis knee: a randomized placebo-controlled trial

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月19日最近更新:

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

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sujit Kumar Tripathy

AIIMS Bhubaneswar

研究点 (1)

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