Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib and Statins vs TNF Inhibitors: TOFSTAT CLINICAL TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Event
研究概览
简要总结
The rationale of our study is to observe the incidence of MACE in RA patients treated with tofacitinib along with statins with one or more cardiovascular disease risks.
PRIMARY OBJECTIVE
- To determine the incidence of MACE in Rheumatoid Arthritis patients with moderate to high disease activity and with one or more cardiovascular disease risks, which are non-responsive to standard conventional DMARDs (cDMARDs) treatment and are prescribed Tofacitinib 5 mg twice daily along with statin 20 mg daily versus TNF Inhibitors.
- The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.
详细描述
This study is a prospective non randomized Clinical Trial Phase-4 aimed at observing the incidence of MACE in RA patients who have moderate to severe disease activity (as determined by the DAS-28 score) and one or more cardiovascular disease (CVD) risks. The patients included in the study will have non-responsiveness to standard cDMARDs treatment and will be prescribed tofacitinib 5 mg twice daily along with statins 20 mg daily as risk modification versus TNF Inhibitor as standard treatment will be the control group.
METHODOLOGY
-
Initial Assessment:
-
Baseline evaluation including DAS-28 score, lipid profile, and assessment of CVD risk factors (hypertension, diabetes, smoking, cholesterol levels, etc.).
-
Recruitment of patients based on inclusion and exclusion criteria.
-
Intervention:
-
In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients.
-
In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment.
-
Patients will be followed up monthly for a period of 6 months.
-
Monthly assessments during follow up: Lipid profile Total cholesterol, LDL, HDL, triglycerides, DAS-28 score, Recording of any CVD events (MACE), Monitoring of any other related complications.
-
Tofacitinib Discontinuation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• RA diagnosis with moderate to severe disease activity, based on DAS-28 despite on > 2 conventional DMARDs.
- •One or more CVD risk factors, such as hypertension, diabetes, smoking, high cholesterol, etc.
- •Age 50 or older.
排除标准
- •Known contraindications to statins.
- •History of major adverse CV events (e.g., recent myocardial infarction or stroke).
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Tofacitinib and statins
In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients.
干预措施: Tofacitinib 5 MG (Drug)
control group TNF inhibitor
o In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment
干预措施: Tofacitinib 5 MG (Drug)
结局指标
主要结局
Major Adverse Cardiovascular Event
时间窗: 6 months
incidence of MACE in Rheumatoid Arthritis patients with moderate to high disease activity and with one or more cardiovascular disease risks, which are non-responsive to standard conventional DMARDs (cDMARDs) treatment and are prescribed Tofacitinib 5 mg twice daily along with statin 20 mg daily versus TNF Inhibitors.
Compare Incidence of MACE in two group
时间窗: 6 months
o The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.
次要结局
- effectiveness of tofacitinib in controlling disease activity(6 months)
- lipid profile(6 months)
研究者
Masooma Hashmat
DR.
Shaikh Zayed Hospital, Lahore