Clinical and Biomarker evaluation of response to oral immunosuppressants in Moderate to Severe Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1. To compare efficacy of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients by evaluating changes in Psoriasis Area and Severity Index (PASI) score.
研究概览
简要总结
Moderate to severe psoriasis patients will be enrolled in the study. After collecting their thorough clinical history and examination at baseline, they will be allotted one of the treatment groups based on randomization. Group A will be given oral Methotrexate, Group B will be given oral Apremilast and Group C will be given oral Cyclosporine. They will be evaluated every 4 weeks for 12 weeks. Outcome will be assessed via Psoriasis Area and Severity Index (PASI), Biomarkers of Psoriasis pathology IL 1, IL 17 and TNF-α, Dermatology Life Quality Index (DLQI), Adverse drug reaction (ADR) and Histopathological changes.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed patients with moderate to severe psoriasis
- •Patients aged
- •PASI score of ≥ 5 or Body surface area involvement of ≥ 10%
- •Patients providing informed consent.
排除标准
- •Patients with uncontrolled or major forms of psoriasis which are life threatening
- •Patients on active topical agents
- •Patients taking other systemic drugs for psoriasis in last 2 months
- •Patient taking other drugs which can interfere with Methotrexate or Apremilast or Cyclosporine
- •Patients on biologics within the past 2 weeks
- •Patients with liver or renal impairment or anaemia or thrombocytopenia or leukopenia
- •Patients with hepatitis B, C, HIV or TB infection
- •Patients with a co-existing comorbidity like diabetes mellitus, uncontrolled hypertension and psychiatric illness 9.
结局指标
主要结局
1. To compare efficacy of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients by evaluating changes in Psoriasis Area and Severity Index (PASI) score.
时间窗: 18 months
2. To evaluate and compare changes in Biomarkers- cytokines like IL 1, IL 17 and TNF α from baseline associated with pathology of psoriasis treated with oral Methotrexate versus oral Apremilast versus oral Cyclosporine.
时间窗: 18 months
次要结局
- 1. To compare changes in Dermatology Life Quality Index (DLQI) score with oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients.(2. To assess the adverse drug reactions, safety & tolerability of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis.)
研究者
Surbhi Jain
Jawaharlal Nehru Medical College, Aligarh Muslim University