Efficacy, Safety and Tolerability of Tofacitinib in addition to Methotrexate versus Tofacitinib as a Monotherapy in Patients with Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Comparing the DAS28 response of both groups at 24 weeks when compared to baseline
研究概览
简要总结
This study evaluates the efficacy, safety, and tolerability of tofacitinib (a Janus kinase inhibitor) when used in combination with methotrexate (MTX) compared to tofacitinib alone (monotherapy) in patients with rheumatoid arthritis (RA). Results indicate that combining tofacitinib with MTX provides greater clinical improvement in RA symptoms than tofacitinib alone, particularly in patients who had an inadequate response to MTX previously. Both treatment approaches showed a manageable safety profile, though adverse events were slightly more frequent in the combination therapy group. Overall, tofacitinib + MTX was found to be more effective, with acceptable tolerability for most patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18-50years diagnosed With Rheumatoid Arthritis on methotrexate from last one month.
排除标准
- •1.Pregnant women and lactating women, those who deny to take contraceptives during study period.
- •Patients who deny to provide Consent form.
结局指标
主要结局
Comparing the DAS28 response of both groups at 24 weeks when compared to baseline
时间窗: 24 weeks
次要结局
- Occurrence of adverse events and serious adverse events (including Change from baseline in clinical laboratory test, Physical Examination and vital sign recorded as adverse events)(24weeks)
研究者
Sanjana Mehta
Chitkara College of Pharmacy