An open label randomised controlled trial to compare the effectiveness of subcutaneous Injection Adalimumab with intra-articular triamcinolone in primary knee osteoarthritis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Improvement in WOMAC pain subscale score (0-100) at 12 weeks.
研究概览
简要总结
The proposed trial is phase 3 open label randomised control trial to compare the efficacy of subcutaneous inj. Adalimumab in comparison to an established therapy of intraarticular Inj. Triamcinolone for symptomatic primary Knee osteoarthritis with evidence of inflammation (clinical/biochemical/radiological). it is a superiority trial. The study will have two arms. each arm will have 37 patients each. after recruitment each patient will undergo contrast MRI of the involved joint to assess the baseline damage and activity in the involved joint. The intervention arm will receive monthly Inj. Adalimumab 40 mg for 3 months and the comparator arm will receive single dose of Intraarticular Triamcinolone. patients will be followed for primary outcome at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Satisfying ACR criteria for classification and reporting of osteoarthritis of knee joint, 1986 Age 40-75 years Symptomatic for at-least 6 months Radiographic Kellgren-Lawrence grade II (definite osteophyte and unimpaired joint space) or grade III (moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour) Visual analog score for knee pain at-least 40 or more on the scale of 0-100.
排除标准
- 未提供
结局指标
主要结局
Improvement in WOMAC pain subscale score (0-100) at 12 weeks.
时间窗: Improvement in WOMAC pain subscale score (0-100) at 12 weeks.
次要结局
- A) Percentage of patients achieving an Osteoarthritis Research Society International/Outcome Measure in Rheumatology Clinical trials (OARSI/OMERACT) response at week 12(12 weeks)
研究者
Dr Israrul Haque
IPGMER Kolkata West Bengal
