COMPARATIVE STUDY OF THE EFFICACY OF METHOTREXATE VERSUS APREMILAST IN THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Outcome name-Psoriasis Area Severity Index(PASI) based on the following parameters:-
研究概览
简要总结
This study is a randomised,participant blinded,parallel group,single centre trial to compare the efficacy of Methotrexate and Apremilast in the treatment of moderate to severe plaque psoriasis.In one group of 21 patients ,tablet Methotrexate will be given as 7.5mg weekly in 3 divided doses whereas in the other group of 21 patients, tablet Apremilast will be started at a dose of 10mg and titrated to maximum of 30mg twice daily upto 16 weeks.Assesment will be done by Psoriasis Area severity Index(PASI) score at baseline,week 4, week 8, week 12 and week 16 where PASI 0,PASI 1,PASI2,PASI3 and PASI 4 are calculated respectively.The efficacy of Methotrexate and Apremilast will be compared using PASI 75 that is time taken for 75% or more reduction in psoriasis lesions from baseline lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients above 18 years with plaque psoriasis.
- •Involvement of 20% or more of body surface area with plaque psoriasis.
排除标准
- •Pregnancy 2)Lactating women.
- •Immunosuppressed individuals 4)Patients with pustular psoriasis.
- •Patients with erythrodermic psoriasis.
结局指标
主要结局
Outcome name-Psoriasis Area Severity Index(PASI) based on the following parameters:-
时间窗: Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16
1. Erythema
时间窗: Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16
2. Induration
时间窗: Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16
3. Desquamation or scaling
时间窗: Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16
次要结局
- PASI-75-To compare the efficacy of Methotrexate and Apremilast by comparing their PASI-75 scores that is time taken for 75% or more reduction of psoriasis lesions from baseline lesions.(Not fixed,depending on the time taken to show 75% or more improvement from baseline lesions for each of the 2 drugs separately.)