To compare efficacy and safety of methotrexate monotherapy with combination of methotrexate and apremilast using standard doses in moderate to severe chronic plaque psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Grade of improvement by reduction of PASI score
研究概览
简要总结
This is a comparative study that intends to study the efficacy and safety of methotrexate monotherapy with combination of methotrexate and apremilast in patients of moderate to severe chronic plaque psoriasis. Patients will be selected based on the eligibility criteria. After obtaining consent detailed history and thorough clinical examination will be performed. They will undergo clinical examination, measurement of weight, blood pressure and blood investigations at each visit.
Patients will be given methotrexate alone or combination of methotrexate and apremilast on alternate basis. PASI score will be measured, side effects relevant to the treatment shall be evaluated on every visit. Patients will be followed up till 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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 having moderate to severe chronic plaque psoriasis with more than 3 percent of body surface area involved by psoriasis with or without psoriatic arthritis.
- •Patients having moderate to severe chronic plaque psoriasis (defined by a score of at least 3 on the Psoriasis Area and Severity Index (PASI).
- •Patients of psoriasis not on any form of systemic antipsoriatic treatment for at least 4 weeks and or topical treatment for at least 2 weeks prior to the initiation of therapy.
排除标准
- •Patients less than 18 years of age.
- •Pregnant and or lactating females.
- •Patients noncompliant with an effective regimen of contraception
- •Hematologic impairment, any acute infection requiring antimicrobial therapy.
- •Uncontrolled hypertension or diabetes mellitus, with BMI more than 30, or known psychiatric illness.
- •Patients having a history of cancer, including skin cancer or hematologic, cerebral or pulmonary neoplasia.
- •Patients who are alcoholic or have a long history of alcohol intake.
结局指标
主要结局
Grade of improvement by reduction of PASI score
时间窗: It will be determined initially at baseline, end of first week, then every two weekly for next four weeks and then every four weekly during the next two months thereafter.
次要结局
- Side effects related to treatment(After each visit)