A comparitive study on the therapeutic efficacy of Tablet Apremilast and Tablet Tofacitinib in the treatment of chronic plaque type psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 80 percent power
研究概览
简要总结
Plaque psoriasis is most common form of psoriasis making up over 80 percent of cases
It usually affects the scalp trunk and extremities
It manifests as erythematous plaque with silvery white scales
Active treatment can successfully reduce symptoms and even achieve a clinical cure
To date there are no direct comparative studies between Apremilast and Tofacitinib in the treatment of chronic plaque psoriasis
Hence this study is novel to detect therapeutic efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having plaque type psoriasis Patients who are willing to give consent to participate in the study Patients who could come for regular follow up.
排除标准
- •Pregnant and lactating mothers Patients with severe liver and kidney diseases Immunocompromised patients History of previous treatment History of known allergy to any drugs Concomitant use of CYP-450 inhibitors or inducers.
结局指标
主要结局
80 percent power
时间窗: Psoriasis Area Severity Index | Patients clinical response at baseline and at 4 weeks and at 8 weeks
95 percent confidence interval
时间窗: Psoriasis Area Severity Index | Patients clinical response at baseline and at 4 weeks and at 8 weeks
P value
时间窗: Psoriasis Area Severity Index | Patients clinical response at baseline and at 4 weeks and at 8 weeks
次要结局
未报告次要终点
研究者
Dr Abirami T
Thanjavur Medical College