Efficacy of Intra-Articular Injection of Etanercept for Moderate and Severe Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain VAS score(Pain Visual Analogue Scale/Score)
研究概览
简要总结
Primary aim: evaluate efficacy of intra-articular injection of etanercept for moderate and severe knee osteoarthritis.
Second aim: investigate the potentiality of serum cytokines (TNF-α, Interleukin 1-α (IL1-α), IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of intra-articular injection of etanercept for moderate and severe knee osteoarthritis.
详细描述
- Background:
Osteoarthritis (osteoarthritis, OA) is a common joint disease. It is characterized by recurrent joint pain, swelling, increasing of disease status, joint deformity and activity disorders. [1]
The pathogenesis of OA has not been fully understood. It may be associated with a variety of factors, such as: mechanics, biochemistry, genetics, and so on. Its main feature is the imbalance between synthesis and catabolism of articular cartilage cells. The imbalance may refer to cell aging, cell apoptosis, local inflammatory factor in joints as well as stress mechanism and so on. [2] OA usually develops in burdened and active joints, such as: the knee, the spine (cervical and lumbar spine), hip and ankle, hand joints, etc. The first session of The National Health and Nutrition Survey (The first National Health and Nutrition Examination Survey, NHANESI) found that 12% of people in The United States have at least one joint in accordance with the clinical diagnosis of OA. [3] Radiographic result shows that rate of American adults knee OA prevalence is 14% and 37%, and women are more common (4-6). A large study found that at least one joint in people over 55 years have radiographic hand OA, and female prevalence is 67%, male is 55% [7].
The OA in Chinese are more likely happened in elder women than men. Prevalence rate could up to 50% in people over the age of 60, and 80% in 75 years old.
Osteoarthritis patients suffer huge pain, and it cause huge economic burden to the society, and it becomes a serious impact on social productivity and lead to huge economic burden [8].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give full consent;
- •According with classification of "Clinical Image" of 1986 American college of rheumatology criteria in osteoarthritis of the knee ;
- •Grade II-III of Kellgren-Lawrence (KL) grading system, revealing synovial inflammation or synovial fluid by combining ultrasound and/or MRI
- •Knee pain for at least 1 Month and Pain VAS Score>4 during the last week;
- •Fertile women agreed to adopt effective contraceptive measures during the test.
排除标准
- •Allergic to pharmaceutical ingredients;
- •Received Tumor Necrosis Factor inhibitor (TNFI) or other biologics preparation within 3 months;
- •Received physical therapy or articular injection, taking antidepressants or antispasmodic, opioids within 3 months ;
- •Patients with history of knee surgery or upcoming surgery within 10 years;
- •Patients accompanied by other complications or joint disease (such as septic arthritis, osteonecrosis,haemochromatosis, ochronosis, etc.);
- •Patients with serious joint deformation or joint deformities;
- •Patients with active or a history of recurrent infections;
- •Patients existing active tuberculosis (TB) or has a history of active TB;
- •Patients with positive on hepatitis b surface antigen or hepatitis c antibody;
- •Patients with a history of severe lung disease, tumor;
- •Patients with severely abnormal function on liver and kidney (liver enzyme > = 2 times normal, creatinine > = normal);
- •Patients with pregnancy, ready for pregnancy or lactation;
- •Patients with other conditions which not suitable for use of Etanercept.
研究组 & 干预措施
Etanercept treatment group
Intra-articular injection of etanercept of 25 mg/w/joint and Health education, exercise and diet guidance; treatment: 5 weeks (If both knees are involved, the more significant symptomatic side is chosen for injection by etanercept)
干预措施: Etanercept (Drug)
Etanercept treatment group
Intra-articular injection of etanercept of 25 mg/w/joint and Health education, exercise and diet guidance; treatment: 5 weeks (If both knees are involved, the more significant symptomatic side is chosen for injection by etanercept)
干预措施: Health education, exercise and diet guidance (Other)
Routine care group
Health education, exercise and diet guidance; treatment: 5 weeks
干预措施: Health education, exercise and diet guidance (Other)
结局指标
主要结局
Pain VAS score(Pain Visual Analogue Scale/Score)
时间窗: baseline to 8 weeks and 12 weeks
Changes from the baseline to 8 weeks and 12 weeks to evaluate the treatment efficacy
KOOS score(The Knee injury and Osteoarthritis Score)
时间窗: baseline to 8 weeks and 12 weeks
Changes from the baseline to 8 weeks and 12 weeks to evaluate the treatment efficacy
次要结局
- MMP1 (ng/ml) level in serum(baseline to 8 weeks and 12 weeks)
- MMP13 (ng/ml) level in serum(baseline to 8 weeks and 12 weeks)
- SF-12 score(MOS 12-item Short Form Health Survey)(baseline to 8 weeks and 12 weeks)
- 40m FPWT score(40 meters fast walking test)(baseline to 8 weeks and 12 weeks)
- Assessment score under MRI(baseline to 8 weeks and 12 weeks)
- IL1-α (pg/ml) level in serum(baseline to 8 weeks and 12 weeks)
- 30s-CST score(30 seconds Sit/chair Test)(baseline to 8 weeks and 12 weeks)
- Assessment score under ultrasound(baseline to 8 weeks and 12 weeks)
- TNF-α (pg/ml) level in serum(baseline to 8 weeks and 12 weeks)
- IL1-β (pg/ml) level in serum(baseline to 8 weeks and 12 weeks)