Effect of Desloratadine as Add-On Therapy in Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease.
The purpose of this study is to evaluate the effectiveness and safety of adding desloratadine to standard therapy in patients with active rheumatoid arthritis. Participants will receive either desloratadine or placebo in addition to their usual treatment.
The study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether desloratadine could be a useful add-on treatment option for patients with rheumatoid arthritis.
详细描述
rheumatoid arthritis. desloratadine has been shown to exhibit additional anti-inflammatory properties beyond its antihistaminic effect.
This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of desloratadine as add-on therapy to standard DMARD treatment in patients with rheumatoid arthritis. Eligible participants will be randomized into two parallel groups to receive either desloratadine, or placebo for a duration of three months.
Clinical assessments will include evaluation of disease activity scores, inflammatory biomarkers, and patient-reported outcomes. Safety and tolerability will be monitored throughout the study period. The findings of this study may provide evidence for novel adjunctive therapeutic strategies in the management of rheumatoid arthritis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.
- •Disease Activity Score in 28 joints (DAS28) greater than 2.
- •Age between 18 and 60 years.
- •Male and female patients.
- •Patients receiving methotrexate in addition to standard conventional therapy.
- •Ability to provide written informed consent.
排除标准
- •Patients with renal or hepatic disease.
- •Known hypersensitivity to the study medications.
- •Current use of antioxidant supplements.
- •History of psychiatric disorders.
- •Use of oral prednisolone at a dose greater than 15 mg per day.
- •Current treatment with biological disease modifying antirheumatic drugs.
- •Pregnant or breastfeeding patients.
- •History of cardiac arrhythmias or prolonged QT interval.
- •Use of medications known to prolong the QT interval.
研究者
Amira Fawzy Mohamed Mashaly
Principal Investigator
Horus University