Comparison of efficacy and adverse effects of methotrexate (0.3mg/kg/week) vs tofacitinib (5mg twice daily) in chronic plaque psoriasis : A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI) 75
研究概览
简要总结
All patients aged 18 to 65 years diagnosed clinically with chronic plaque psoriasis coming to Dermatology OPD, SSH, BHU those who fulfill the inclusion criteria will be included in the study. All patients will be randomly allocated equally to 2 groups.
Group 1 will be given Methotrexate intramuscular injection 0.3mg/kg/week with supportive treatment (proton pump inhibitor, emollient, antihistamines) for 4 months.
Group 2 will be given oral Tofacitinib 5mg twice daily for 4 months with supportive treatment (emollient, antihistamines) for 4 months.
All patients will be followed up every 2 weeks for the first 4 weeks and then every 4 weeks thereafter till 4 months. The affected body surface area, PASI will be recorded along with other relevant baseline clinical investigations and documentation of adverse effects will be done.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All clinically diagnosed cases of psoriasis who give their consent to participate in study with BSA more than 10 percent and/or PASI more than
- •Cumulative methotrexate dose less than 1.5g.
- •Not taking systemic therapy for 1 month and topical therapy for 2 weeks prior to enrolment.
排除标准
- •Pregnancy or lactation.
- •History of alcoholism.
- •Taking hepatotoxic or nephrotoxic drugs.
- •Haemoglobin less than 8 gm/dL.
- •TLC less than 4000 cells/mm
- •Platelet count less than 1 lakh/mm
- •Lymphocytes less than 1500/mm
- •Raised SGPT/OT more than or equal to twice the normal limit at baseline or more than equal to thrice the normal limit at follow up.
- •Raised Total bilirubin more than 1.2 or 30percent increase in baseline.
- •Serum creatinine values of more than 1.4 mg/dl at baseline or more than 30 percent increase in baseline at two consecutive visits.
- •Any evidence of active or latent tuberculosis.
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) 75
时间窗: Psoriasis Area and Severity Index (PASI) 75 at baseline, 2 weekly for 4 weeks, 4 weekly for 12 weeks thereafter
次要结局
- PASI 90, PASI 100(PASI 90, PASI 100 at baseline, 2 weekly for 4 weeks, 4 weekly for 12 weeks thereafter)
研究者
Dr Satyendra Kumar Singh
Institute of Medical Sciences