Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Disease activity score in 28 joints (DAS-28)
研究概览
简要总结
Montelukast is widely used in patients with asthma. Several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators.
Considering the probable enhanced antiarthritic effects of montelukast; it could be hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who remain poorly controlled despite initial optimal guidelines directed medical treatment. Therefore, this study aims to evaluate the potential added benefits of montelukast use in conjunction with csDMARDs in RA patients with moderate and high disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients ages ≥ 18 years old.
- •Patients diagnosed with RA according to American College of Rheumatology/European league Against Rheumatism (ACR/ EULAR) 2010 criteria (25) presented with disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) >3.
- •Patient received stable regimen of one or more csDMARDs for at least the past 3 months.
排除标准
- •Patient taking biological DMARDs.
- •Known hypersensitivity to montelukast.
- •Patients receive montelukast for any other indications.
- •Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits).
- •Patients with impaired kidney (estimated glomerular filtration rate (eGFR) < 30 ml/min).
- •Pregnancy and lactation.
- •Patients with active or severe infections.
- •Patients with other inflammatory or autoimmune diseases and malignancies.
- •Patients with any psychiatric disorder.
- •Patients taking IV, IM, orally (dose > 10 mg daily) or intra articular corticosteroides,
研究组 & 干预措施
Montelukast Group
Patients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 16 weeks.
干预措施: Montelukast (Drug)
Montelukast Group
Patients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 16 weeks.
干预措施: Conventional DMARDs (Drug)
Control Group
Patients will receive conventional DMARDs plus placebo tablet daily for 16 weeks
干预措施: Placebo (Drug)
Control Group
Patients will receive conventional DMARDs plus placebo tablet daily for 16 weeks
干预措施: Conventional DMARDs (Drug)
结局指标
主要结局
Disease activity score in 28 joints (DAS-28)
时间窗: 16 weeks
Scale assessing severity of rheumatoid arthritis based on number of tender , swollen joints , CRP levels ,and patient self-assessment of his condition (global health assessment) . Whereas "28" describes the number of different joints including in the measurement :proximal interphalangeal joints (10 joints),metacarpophalangeal joints (10),wrists (2),elbows (2),shoulders (2),knees (2). A DAS-28 value \< 2.6 corresponds to remission,value between 2.6 and 3.2 corresponds to a low disease activity, value between 3.2 and 5.1 corresponds to a moderate disease activity, and DAS28 value \>5.1 corresponds to a high disease activity.
次要结局
- Assessment of patient's QOL using Health Assessment Questionnaire Disability index (HAQ-DI)(16 weeks)
研究者
Noha Mansour
Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department
Mansoura University