Evaluating the effectiveness of low-dose short-term oral methylprednisolone compared to single intramuscular dose in bridge therapy for rheumatoid arthritis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- To estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or intramuscular prednisone in addition to standard of care therapy
研究概览
简要总结
This is an open label randomised control trial from a single centre in India for evaluating the effectiveness of low dose short term oral methylprednisolone compared to a single intramuscular dose in bridge therapy for Rheumatoid arthritis. The primary outcome is to estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or intramuscular methylprednisolone in addition to standard of care therapy. Th secondary outcomes are to estimate difference in proportion of patients reporting EULAR good or moderate response at 2 months, difference in trajectory of response in HAQ and RAPID 3 at day 7, day 30 and day 60, difference in DAS 28 ESR improvement at day 30 and day 60, difference in proportion of patients achieving delta HAQ more than 1.2 at day 7, day 30 and day 60, differences in adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed Rheumatoid arthritis patients with symptoms duration less than 24 months
- •Diagnosed as per ACR/EULAR classification criteria
- •DAS28 ESR more than 3.2.
排除标准
- •Patients treated with DMARDs for more than 3 months prior to enrolment except HCQ
- •Patients treated with prednisolone in the past 1 month
- •Patients with evidence of hypothalamic pituitary adrenal axis suppression
- •Patients with absolute contraindication to corticosteroids as per treating physician
- •Presence of active infections
- •Patients who do not give consent.
结局指标
主要结局
To estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or intramuscular prednisone in addition to standard of care therapy
时间窗: Day 7 | Day 30 | Day 60
次要结局
- 1. Difference in proportion of patients reporting EULAR good or moderate response at 2 months(2. Difference in trajectory of response in HAQ and RAPID 3 at day 7, 1month and 2 months)
研究者
Dr Vishnupriya Duddugunta
St Johns Medical College and Hospital