The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks
研究概览
简要总结
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone.
Study design: A randomized, single-blind, parallel controlled and one center trial design.
Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed.
Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
详细描述
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone.
Study design: A randomized, single-blind, parallel controlled and one center trial design, the study period is 4 weeks.
Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group according to the random number table. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed.
Index of effect evaluation: 1) Articular ultrasound, OMERACT-EULAR composite PDUS synovitis score will be used to evaluate the condition of articulation; 2) Disease activity score, DAS28-CRP, DAS28-ESR; 3) Health Assessment Questionnaire, HAQ; 4) Rheumatoid and arthritis outcome score, RAOS; 5) composite change index, CCI score; 6) diameter of knee joint; 7) knee flexion range.
Hypothesis
The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-65 years
- •Patients must be diagnosed as rheumatoid arthritis according to the 2010 ACR classification diagnostic criteria for RA for at least 6 months.
- •Patients' knee is swelling or has effusion.
- •Patients have used the same dosage of DMARDs or biologics for at least 6 weeks and continue using the drug until the end of the study.
- •If patients are using glucocorticoid or NSAIDs, the dosage must be stabilized for at least 4 weeks and continue until the end of the study.
- •Patients must understand the aim and steps of this study, can come back for follow-up timely.
排除标准
- •Patients' knee is out of shape. X-ray shows a moderate or severe damage of subchondral bone, or joint space is less than 3 mm.
- •Patients have received intra-articular injection of glucocorticoid or TNFi, joint replacement, or synovectomy.
- •Patients is suffering from other autoimmune diseases or Spondyloarthritis.
- •The skin of knee is damaged severely.
- •Patients is suffering from pulmonary tuberculosis, or Chest X-ray shows lesion signs related to tuberculosis.
- •For the last 3 months, patients have participated in other new drug's clinical trial.
- •Other patients who have been thought not suitable for the study by researchers.
研究组 & 干预措施
Intra-articular Tocilizumab
Tocilizumab, solution, 80mg intra-articular.
干预措施: Intra-articular Tocilizumab (Drug)
Intra-articular Compound Betamethasone
Compound betamethasone, solution, 14mg intra-articular
干预措施: Intra-articular Compound Betamethasone (Drug)
结局指标
主要结局
change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks
时间窗: 0 and 4 weeks
use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score
次要结局
- change from disease activity score at 4 weeks(0 and 4 weeks)
- change from Health Assessment Questionnaire at 4 weeks(0 and 4 weeks)
- change from Rheumatoid and arthritis outcome score at 4 weeks(0 and 4 weeks)
- change from diameter of knee joint at 4 weeks(0 and 4 weeks)
- change from knee flexion range at 4 weeks(0 and 4 weeks)
- change from composite change index at 4 weeks(0 and 4 weeks)
研究者
Jian Zhu
Associated Prof. of Medicine, Deputy Director of Rheumatology
Chinese PLA General Hospital