Evaluation of the Effect of Cilostazol on the Clinical Outcomes of Rheumatoid Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in the DAS-28 CRP score
研究概览
简要总结
The goal of this study is to evaluate the effect of cilostazol on Rheumatoid Arthritis patients. It aims to answer the questions of :
- Will Cilostazol improve the disease severity and quality of life in Rheumatoid arthritis patients?
- Will Cilostazol decrease the oxidative stress, inflammation and endothelial dysfunction in Rheumatoid arthritis patients?
Participants will be randomized into two arms either treatment or control the treatment group will be asked to take Cilostazol 100 mg twice daily in addition to the usual DMARD (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide), while the control group will be taking the usual DMARDs only.
Patients in both arms will be followed-up every 2 weeks through out the 6-month duration of the study.
详细描述
Rheumatoid Arthritis (RA) is an autoimmune disease affecting joints. It usually affects females more. The available treatment aims to slow down disease progression and control the disease symptoms. Treatment is classified into either the conventional DMARDs (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide) or Biological DMARDs such as an Anti-TNF alpha ( Certolizumab, Infliximab , Etanercept or Golimumab) or non-TNF biologics (Rituximab, Abatacept or Tocilizumab). Both classes have their drawbacks. The conventional DMARDs is not effective for many patients and the biological DMARDs have a high cost making their use limited to patients with medical insurance or patients who can afford it, thus making it necessary to find new medications which can improve the outcomes in patients with RA.
Cilostazol is an antiplatelet agent used mainly for intermittent Claudication. Recently many preclinical trials have shown efficacy of cilostazol in RA via it's anti-inflammatory action. it also decreases the oxidative stress which is high in ٌRA patients.
Patients will be randomized into two arms , one which is treatment and the other is control the treatment group will be asked to take Cilostazol 100 mg twice daily in addition to the usual DMARD (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide), while the control group will be taking the usual DMARDs only.
Patients in both arms will be followed-up every 2 weeks through out the 6-month duration of the study.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients. (>18 years old).
- •Moderate to high disease activity (DAS28-CRP>3.2).
- •Patients receiving stable cDMARD regimen for at least 3 months before inclusion in the study.
排除标准
- •Hypersensitivity to cilostazol.
- •Heart failure.
- •Pregnant and lactating women.
- •Patients with liver impairment (ALT or AST > 3* ULN).
- •Patients with renal impairment (CrCl<60 mL/min).
- •Patients receiving any other antiplatelet or anticoagulant
研究组 & 干预措施
Cilostazol arm
35 patients receiving conventional synthetic disease modifying antirheumatic drugs in addition to Cilostazol 100 mg twice daily for 6 months.
干预措施: Cilostazol 100 MG (Drug)
Cilostazol arm
35 patients receiving conventional synthetic disease modifying antirheumatic drugs in addition to Cilostazol 100 mg twice daily for 6 months.
干预措施: conventional synthetic antirheumatic drugs (Drug)
Control
35 patients receiving conventional synthetic disease modifying antirheumatic drugs for 6 months.
干预措施: conventional synthetic antirheumatic drugs (Drug)
结局指标
主要结局
Change in the DAS-28 CRP score
时间窗: Baseline, after 3 months , After 6 months
DAS-28 score is used to asses disease severity in Rheumatoid Arthritis. It incorporates the swollen and tender joints present in 28 joints together with the c-reactive protein measurement into an equation to calculate the disease severity. 0.56\* √(TJC28) + 0.28\* √(SJC28) + 0.36\*ln (CRP + 1) +0.014\*(GH) + 0.96 where TJC:is tender joint count SJC is : swollen joint count GH:patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst a number is given which is equal to a specific disease severity. website to calculate the DAS-28 score : https://www.4s-dawn.com/DAS28/
次要结局
- TNF α(Baseline and at 6 months)
- phosphorylated Adenosine monophosphate-activated protein kinase (p-AMPK)(Baseline and at 6 months)
- Cilostazol safety(From date of randomization then every two weeks up to 6 months)
- Health Assessment Questionnaire(Baseline, after 3 months , After 6 months)
- Total antioxidant capacity (TAC)(Baseline and at 6 months)
- Malondialdehyde (MDA)(Baseline and at 6 months)
- Vascular cell adhesion protein 1(VCAM-1)(baseline and at 6 months)
研究者
Omar Ashraf Mohamed
Teaching Assistant
Misr International University