The Phosphodiesterase 3 Inhibitor Cilostazol as Adjunct to Methotrexate in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change in DAS-28 CRP score
研究概览
简要总结
This study aims at evaluating the therapeutic effects of Cilostazol as adjuvant therapies to low dose of Methotrexate in patients with Rheumatoid Arthritis and to evaluate their impact on Cyclic adenosine monophosphate(CAMP), Heme Oxygenase-1(HO-1).
详细描述
Rheumatoid arthritis (RA) is characterized by the presence of hyperplastic synovium in association with immune-mediated inflammatory synovitis associated with chronic production of proinflammatory cytokines, which lead to cartilage and bone degradation .This study is a randomized, controlled double blind placebo-controlled ,prospective study to evaluate the potential therapeutic effects of Cilostazol on synovial inflammation when administered as add-on treatments to the low dose of Methotrexate.
A total of 70 RA patients with active disease will be recruited from Outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the study. They will be diagnosed with RA according to the American College of Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria).
RA Patients who will meet the inclusion criteria will be enrolled in the study.
They will be classified into two groups:
Group 1: 35 RA patients who will receive Methotrexate and placebo for 12 weeks and serve as the control group.
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, Care Provider, Investigator)
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 (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria (13) i.e 28 joints disease activity score (DAS-28) >2.
- •Age range between 18 and 60 years old.
- •Patients receive methotrexate; approximately the same doses of non steroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids (Prednisolone < 15 mg) will be allowed to enroll the trial.
- •Intravenous, intra-articular or intramuscular corticosteroids; intra articular hyaluronate sodium; biological DMARDs and other conventional DMARDs will not be permitted less than 4 weeks before the first dose of cilostazol.
排除标准
- •Patients with diabetes, congestive heart failure, other heart disease (arrhythmia, hypertension, ischemic heart diseases), severe anemia, bleeding problems, other inflammatory diseases, active infection, other illness except rheumatoid arthritis.
- •Patients on low doses of aspirin
- •Patients on anticoagulants.
- •Patients with renal or hepatic diseases.
- •Patients receiving oral prednisolone greater than 15 mg/day.
- •Patients receiving biological DMARDs.
- •Patients with hypersensitivity to study medications.
- •Patients using antioxidants .
- •Pregnant and lactating females.
研究组 & 干预措施
Cilostazol and Methotrexate
Participants in this arm will receive Cilostazol 50 mg twice daily with Methotrexate for rheumatoid arthritis for 12 weeks.
干预措施: Cilostazol (Drug)
Cilostazol and Methotrexate
Participants in this arm will receive Cilostazol 50 mg twice daily with Methotrexate for rheumatoid arthritis for 12 weeks.
干预措施: Methotrexate (Drug)
Placebo and Methotrexate
Participants in this arm will receive Placebo with Methotrexate for rheumatoid arthritis for 12 weeks.
干预措施: Methotrexate (Drug)
Placebo and Methotrexate
Participants in this arm will receive Placebo with Methotrexate for rheumatoid arthritis for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
change in DAS-28 CRP score
时间窗: Baseline,12 weeks
Clinical assessment by calculating of 28-joint count Disease Activity score (DAS-28) using C-reactive protein according to calculating formula(DAS28 (CRP) = 0.56\*√(Tender joint count28) +0.28\*√(Sowallen joint count28)+0.36\*ln (CRP+1)\*1.10+1.15 will done where high disease activity ≥ 5.1, low disease activity ≤ 3.2, and remission \< 2.6.
Change in Multi Dimensional Health Assessment score
时间窗: Baseline,12weeks
Functional assessment will be assessed through Multi Dimensional Health Assessment score that include 14 items Health Assessment Questionaire .The score of the HAQ Questionnaire is calculated from the mean of the sum of the responses of the items where each item is scored from 0-3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. in addition, MDHAQ includes the assessment of morning stiffness (MS) duration in minutes.
Change in Visual analog scale for pain
时间窗: Baseline,12 weeks
Visual analog scales which ranges from 0 to 10,it is a psychometric scale that is generally used in hospitals and clinics by doctors to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient.
次要结局
- Change in the serum level of the assessed biological marker C-reactive protein(Baseline,12weeks)
- Change in the serum level of the assessed biological marker Nuclear factor kabba-B p65(Baseline,12weeks)
- Change in the serum level of the assessed biological marker Hemeoxygenase-1(Baseline,12weeks)
- Change in the serum level of the assessed biological marker Cyclic adenosine monophosphate(Baseline,12weeks)
研究者
Samar Mohammed Mahmoud Eldadamouny
Clinical Pharmacist
Tanta University