A Non-Randomized, Double-Arm, Open-Labelled, Multi-Centre, Interventional, Prospective Investigator Initiated Study To Evaluate The Safety And Efficacy Of Intraarticular Triamcinolone Acetonide (Kenacort®) Injection Vs Standard Of Care In Patients With Rheumatoid Arthritis Flare
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess and compare the mean change in severity of pain measured by VAS score from baseline to week 2 visit.
研究概览
简要总结
Rheumatoid arthritis (RA) is a very common chronic inflammatory disease characterized by joint swelling, joint tenderness, and destruction of synovial joints. The prevalence of RA ranges from 0.1–5%. The onset of RA usually occurs between the ages of 30 and 50 years with female preponderance. Incidence of RA in men is estimated to be about 25 per 100,000 persons and for women it is about 54 per 100,000 persons in the United States. RA eventually leads to severe disability and premature mortality.
RA is considered an autoimmune disease. The presence of autoantibodies such as rheumatoid factor (RF) and anti–citrullinated protein antibody (ACPA) precede the clinical manifestation of RA.
Injection of corticosteroids such as Triamcinolone into the synovial joint is now firmly established procedure in the management of rheumatic disease. The RA flare may be suppressed by a single intra-articular injection of corticosteroid when the arthritis involves predominantly one joint.
The goal of directing potent anti-inflammatory treatment into an inflamed joint is the rapid resolution of synovitis. Local treatment may lead to complete resolution of the signs and symptoms of arthritis, thus obviating the need for regular systemic therapy. Also, intra-articular corticosteroid injections helps to avoid adverse effects of systemic corticosteroids.
Currently there is limited data by controlled trials of intra-articular steroids versus systemic agents in any of these contexts. Hence, this study is designed to evaluate the safety and efficacy of Triamcinolone Acetonide (Kenacort®) injection when compared to systemic corticosteroids. Patients with Rheumatoid Arthritis (RA) flare in the knee joint will be evaluated after 12 weeks of an intra-articular injection in the Indian population.
Croissance Clinical Research is supporting Data Management activities for this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient has a confirmed diagnosis of Rheumatoid Arthritis and on stable therapy for RA in the last 3 months as per ACR 2010 criteria.
- •Evidence of disease flare-up in the knee joint
- •Patient on at least 1 DMARD for the past 6 month
- •Stable dose of DMARD in the last 6 weeks
- •Patients who require intra-articular glucocorticoid injection in the knee joint.
- •Participants should have the ability to understand the requirements of the study.
- •Participants willing to abide by the study restrictions and return for the required assessments.
- •Participants willing to provide an written informed consent.
排除标准
- •Patients not willing to give informed consent
- •Patients with only mild disease
- •Patients currently on intravenous or depo steroids.
- •In the Principal Investigator’s opinion patient who may require changes in current DMARDs including its dose strength during the study duration.
- •Patients with septic arthritis
- •Any other clinically significant disorder which needs treatment or serious systemic illness
- •Alcoholics and/or drug abusers.
- •Known history of hypersensitivity to the trial drug or any of its ingredients.
- •Pregnant / lactating woman.
- •Patients who have completed participation in any other clinical trial during the past six (06) months.
- •Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
To assess and compare the mean change in severity of pain measured by VAS score from baseline to week 2 visit.
时间窗: Week 2
To assess and compare the mean change in reduction of swelling on the Likert scale from baseline to week 2 visit.
时间窗: Week 2
次要结局
- To assess and compare the mean change in frequency and duration of morning stiffness from Baseline to Week 6 & Week 12 visit(To compare the pattern of frequency morning stiffness between two different arms)