Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Efficacy Achievement
研究概览
简要总结
Psoriasis is a chronic inflammatory dermatoses which include well demarcated scaly erythematous plaques on whole body including scalp role of methotrexate vs tofacitinib is compared in this study
详细描述
Comparison between safety and efficacy of oral methotrexate and tofacitinib in chronic plaque psoriasis is to be determined in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18- 70 years of either gender.
- •Only patients with Psoriasis Area and Severity Index (PASI) score of 10 or above, and/or Body Surface Area (BSA) involvement of 10% or more, will be included.
- •Duration of plaque psoriasis for at least 6 months prior to the study.
- •Psoriasis that has not shown adequate response to topical therapies
排除标准
- •Individuals with other forms of psoriasis or other significant dermatological conditions that might interfere with the assessment of psoriasis.
- •Participants currently receiving systemic corticosteroids, biologics, or any other immunosuppressive agents within 4 weeks prior to the start of the study will be excluded.
- •Known hypersensitivity or contraindications to either methotrexate or tofacitinib.
- •History of significant liver, kidney, hematologic/bleeding disorder, gastrointestinal/acid peptic disease, or immune system disorders.and any history of tuberculosis and malignancy.
- •Pregnant or lactating women will not be eligible for the study.
研究组 & 干预措施
Group mTX
Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase
干预措施: Methotrexate (Drug)
Tofacitinib
Tofacitinib is janus kinase inhibitor and had a role in treatment of psoriasis and psoriatic arthritis
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Efficacy Achievement
时间窗: Baseline to Week 12 of treatment
The primary outcome will be the proportion of participants who demonstrate a minimum 75 percent reduction in the Severity Index (PASI-75) from baseline to Week 12 of treatment. A participant will be classified as "Achieved" if the Week-12 PASI score reflects a reduction of 75 percent or greater from the baseline measurement, and "Not Achieved" if this threshold is not met.
次要结局
- Percentage Reduction in PASI Score(From Baseline to Week 12)
研究者
Maryam Fatima
Principal Investigator
Lahore General Hospital