The Effect of Nicorandil on Disease Activity in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Evaluation of treatment Efficacy
研究概览
简要总结
The aim of this clinical trial is to determine whether nicorandil works in minimizing disease severity in patients with rheumatoid arthritis. The study will also assess the safety and tolerability of nicorandil. The main questions it aims to answer are:
- Could nicorandil improve disease severity and symptoms of rheumatoid arthritis?
- Does nicorandil lower the number of times participants need to use pain relieve medications?
- Does the nicorandil improve participants functionality and ability to carry out daily activity?
- Does nicorandil correct disease-associated damage and inflammation?
- What side effects do participants have when taking nicorandil? Researchers will compare nicorandil to a placebo (a look-alike substance that contains no drug) to see if nicorandil works to decrease symptoms and severity of rheumatoid arthritis.
Participants will:
- Take nicorandil or a placebo two times daily for 3 months
- Visit the clinic once every month for checkups
- Keep a diary of their symptoms and the number of times they use a pain reliever
详细描述
Rheumatoid arthritis (RA) is a progressive systemic inflammatory autoimmune disease mainly affecting joints. Adequate treatment and control are important to prevent disease progression and extra-articular complications. Nicorandil is a nicotinamide anti-anginal drug with a potent anti-ischemic, anti-hypoxic, anti-inflammatory and immunomodulatory characteristics that may be potentially effective in the management of autoimmune diseases. Therefore, nicorandil would be a candidate intervention based on previous clinical trial on non-RA patients and animal studies on RA models.
This randomized stratified double-blinded clinical trial will recruit 70 patients based on inclusion criteria. Patients will be randomized to either receive nicorandil 10 mg twice daily or placebo twice daily in addition to conventional treatment for RA for 3 months. The study will be carried out according to ethical considerations.
Patients will be evaluated on monthly bases. At baseline patient history, demographic data, medical and medication history will be documented through patient interview and medical records. At baseline and after completion of 3 months of treatment, investigator will evaluate the patient for treatment safety and efficacy. Evaluation will include disease activity, frequency for using analgesics, quality of life, level of inflammatory mediators, and cartilage integrity. Throughout the study, patient will be followed up closely for any reported adverse effect. At the end of the study, statistical analysis will be done using SPSS software package and the appropriate test will be used.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years).
- •Confirmed diagnosis with RA according to ACR/EULAR 2010 criteria.
- •Moderate to severe disease activity (DAS-28 ˃ 3.2).
- •Stable on conventional treatment for at least 3 months.
- •Adequate kidney and liver function.
排除标准
- •Other autoimmune diseases
- •Poor patient compliance
- •Malignancy or history of malignancy
- •Pregnancy or lactation.
- •Patients receiving bDMARDs or tsDMARDs.
- •Hypersensitivity to nicorandil.
- •Left ventricular heart failure or severe hypotension (SBP ˂100 mmHg).
- •History of cardiogenic shock.
- •History or active gastric ulcer.
- •Use of drugs contraindicated with nicorandil (e.g., sildenafil, tadalafil, vardenafil, tricyclic antidepressants, or guanyl cyclase).
研究组 & 干预措施
Nicorandil group
Patients will receive the standard of conventional treatment (cDMARDs with/without corticosteroids) in addition to nicorandil 10 mg tablets twice daily for 3 months (12 weeks).
干预措施: Nicorandil Oral Tablet (Drug)
Nicorandil group
Patients will receive the standard of conventional treatment (cDMARDs with/without corticosteroids) in addition to nicorandil 10 mg tablets twice daily for 3 months (12 weeks).
干预措施: conventional synthetic antirheumatic drugs (cDMARDs) (Drug)
Placebo group
Patients will receive the standard of conventional treatment (cDMARDs with/without corticosteroids) in addition to placebo tablets twice daily for 3 months (12 weeks).
干预措施: Placebo (Drug)
Placebo group
Patients will receive the standard of conventional treatment (cDMARDs with/without corticosteroids) in addition to placebo tablets twice daily for 3 months (12 weeks).
干预措施: conventional synthetic antirheumatic drugs (cDMARDs) (Drug)
结局指标
主要结局
Evaluation of treatment Efficacy
时间窗: At baseline and at the end of the study (3 months (12 weeks)).
Treatment efficacy will be evaluated using disease activity score DAS-28 (ESR) and the frequency of using analgesics due to arthritis pain. Erythrocyte sedimentation rate (ESR) (mm/hr) will be measured using the Westergren method. Score interpretation: Score \<2.6 means disease remission, 2.6-3.2 means low disease activity, \>3.2-5.1 means moderate disease activity, and \>5.1 means high disease activity. After treatment intervention, a DAS-28 score reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement. The frequency of using analgesics will be documented by patient using a diary sheet and weekly evaluation.
次要结局
- Evaluation of quality of life (QOL)(At baseline and at the end of the study (3 months (12 weeks)).)
研究者
Sondos Sherif Ismail
Assistant Lecturer in Clinical Pharmacy Department
Ain Shams University