Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- ACR 20%
研究概览
简要总结
Rheumatoid arthritis (RA) is an inflammatory autoimmune polyarthritis affecting ∼1% of the world population, resulting in the loss of joint function and progressive structural damage in affected joints. Fexofenadine has been widely used to treat various allergic diseases, like allergic rhinitis, conjunctivitis and chronic idiopathic urticaria. the molecular mechanisms underlying fexofenadine mediated inhibition of TNF-α signalling
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of biological DMARDS.
- •History/presence of acute heart disease, liver and kidney diseases, COPD
- •Intolerance or allergy to fexofenadine or methotrexate
- •Alcohol abuse
- •Any changes in using medication (changing the dosage or type of medicines
- •Receive hormone replacement therapy, warfarin, and other anticoagulants
研究组 & 干预措施
Fexo group
干预措施: Fexofenadine (Drug)
Placepo
干预措施: Placebo (Drug)
结局指标
主要结局
ACR 20%
时间窗: at week 12
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
CRP
时间窗: at week 12
the level of CRP
(HAQDI)
时间窗: at week 12
HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section
次要结局
- TNF-α(at baseline and at week 12)
- IL6(at baseline and at week 12)
研究者
engy wahsh
lecturer of clinical pharmacy
October 6 University