NCT06456489招募中3 期
Revealing the Potential of Intravenous Pulse Steroid Therapy; Impressive Results in Attaining Remission or Low Disease Activity in Refractory Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- remission or low disease activity
研究概览
简要总结
Remission or low disease activity in active rheumatoid arthritis
详细描述
Assessment of rheumatoid arthritis activity by Disease activity score DAS28, DAS28 Erythrocyte sedimentation rate (ESR), American college of rheumatology (ACR) 20, ACR 50, ACR 70 will be done at baseline and every month for 3 consecutive months for both groups.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory rheumatoid arthritis patients
排除标准
- •Other connective tissue diseases
- •Endocrine diseases such as DM and thyroid disorders
研究组 & 干预措施
pulse steroid solumedrol
Experimental
125 mg of methylprednisolone IV pulse will be administered for two consecutive days followed by oral steroid for 2 weeks with gradual withdrawal.
干预措施: Solumedrol (Drug)
without pulse
Placebo Comparator
patients will not receive any additional treatment
干预措施: Solumedrol (Drug)
结局指标
主要结局
remission or low disease activity
时间窗: 4 months
Outcome measurements for both groups will be done at baseline and every month for 3 months. DAS28, DAS28 ESR ACR20 ACR50 ACR70
次要结局
未报告次要终点
研究者
研究点 (1)
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