Comparative therapeutic evaluation of oral tofacitinib versus methotrexate in moderate to severe chronic plaque Psoriasis - A hospital based randomized control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Clinical response as indicated by PASI75 score after 16 weeks of treatment
研究概览
简要总结
We are conducting this randomized controlled trial in the dept. of dermatology and venerology , AIIMS gorakhpur , comparing the safety and efficacy of oral tofacitinib versus oral methotrexate in patients of moderate to severe chronic plaque psoriasis over the course of 16 weeks.
POPULATION/ PARTICIPANTS: Patients visiting dermatology OPD with diagnosed case of chronic plaque psoriasis diagnosed clinically with age between 18-65 years, satisfying the inclusion criteria, and willing to participate in the study.
INCLUSION CRITERIA: patients fulfilling the following criteria will be included in the study
1. Patients between the age group of 18 – 65 yrs.
2. BSA > 5% and PASI score > 3
3. Patients with well controlled diabetes, hypertension and thyroid disorder.
EXCLUSION CRITERIA: patients fulfilling the following criteria will be excluded from the study
1. Patients not consenting to the study.
2. Patient with deranged biochemical profile.
3. Pregnant and lactating women.
PRIMARY END POINT :
1. Comparison of PASI75 between the two study groups after 16 weeks of treatment.
SECONDARY ENDPOINT :
1. Mean improvement in Body Surface Area (BSA) involvement by the end of 16 weeks.
2. Achievement of PASI 90.
3. Improvement in Severity of Nail Psoriasis Score (SNAPS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.patients of 18 to 65 years of age 2.BSA more than 5% and PASI more than 3 3.Patients with well controlled diabetes, hypertension and thyroid disorder.
排除标准
- •Patients not consenting to the study.
- •Patient with deranged biochemical profile.
- •Pregnant and lactating women.
结局指标
主要结局
Clinical response as indicated by PASI75 score after 16 weeks of treatment
时间窗: 16 weeks
次要结局
- 1. Assessing The Dermatology Life Quality Index (DLQI) before , during and after the completion of 16 months.(2. Assessing the changes in Severity of Nail Psoriasis Score (SNAPS) after completion of 16 weeks.)
研究者
Dr Rohit Kumar Singh
Dept. of dermatology and venerology , All india institute of medical sciences, gorakhpur