CTRI/2023/06/053443尚未招募不适用
A study of Efficacy and safety of oral tofacitinib vs methotrexate in management of moderate to severe chronic plaque psoriasis
未提供1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年1月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- improvement in PASI by 75% from baseline at 12 week
研究概览
简要总结
Methotrexate is the gold standard drug in management of moderate to severe chronic plaque psoriasis but unfortunately is associated with acute toxicity and potentially severe side effects such as cirrhosis.
Other available alternative is biologicals but their use is limited due to higher cost.
Tofacitinib is a JAK-STAT inhibitor found to be useful in chronic plaque psoriasis. If tofacitinib is found to be non-inferior to methotrexate, another safer and affordable 1st line drug can be used for management of moderate to severe chronic plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex and age 18-70 years.
- •2.PASI>12 or BSA>10%.
排除标准
- •1.Age less than 18 or more than 70 years 2.Individuals with severe anaemia, leukopenia(lymphocytes<500 cells/mm3, ANC<500 cells/MM3,Hemoglobin <9g/dl), pre-existing liver diseases, bone marrow pathologies causing cytopenia, 3.Individuals with heavy alcohol consumption (>14 units/week) or heavy smokers.
- •4.Individuals on concomitant medications such as high dose vitamin D, oral/topical steroids, PUVA, Acitretin, Dapsone, Sulfamethoxazole, Trimethoprim 5.Pregnant and lactating women 6.Patient having pre-existing uncontrolled Diabetes mallitus , Hypertension 7.Patients who have taken any immunosuppressant drugs, homeopathic/herbal medications in last 4 weeks.
- •8.Patients with malignancies/ history of malignancy.
- •9.Patients with risk/history of thromboembolism, cardiovascular accidents.
- •10.Patients with active infection, active/latent tuberculosis.
- •11.Patients found to have abnormal laboratory parameters that would increase the risk of adverse effect.
结局指标
主要结局
improvement in PASI by 75% from baseline at 12 week
时间窗: improvement in PASI by 75% from baseline at 12 week
次要结局
- Improvement in PASI by 100% from baseline(Physicians global assessment)
研究者
研究点 (1)
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