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临床试验/CTRI/2019/01/017362
CTRI/2019/01/017362尚未招募不适用

An open-labelled randomised comparative evaluation of therapeutic efficacy and safety of Apremilast versus Methotrexate in the treatment of patients with Chronic plaque psoriasis

RATHIPRIYADHARSHINI R1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Improvement in PASI[Psoriasis Area and Severity Index] more than 75% from baseline

研究概览

简要总结

Psoriasis is a common, chronic inflammatory,immune mediated, hyperproliferative condition affecting primarily the skin. It is associated with significant reduction in the quality of life. There are several modalities of treatment available but none is satisfactory in acheiving significant clearance of lesions. Apremilast is the new orally active Phosphodiestrase-4 inhibitor found to be effective in treatment of psoriasis with negligible adverse effects and also eithout any need for rotine monitoring of blood parameters. Methotrexate is a well-known drug in the treatment of psoriasis for years. Eventhough there is reduction in the morbidity, it is associated with frequent side effects and patient dissatisfaction. This study is to evaluate the efficacy and safety of Apremilast in our setting and to compare the same with the conventionally used Methotrexate in the treatment of Chronic Plaque Psoriasis.

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

  • Those With chronic plaque psoriasis involving >10%BSA Those who sign the written consent form prior to participation in the study.

排除标准

  • pregnancy lactation abnormalities in LFT,RFT,CBC hypertension and diabetes active tuberculosis/ HIV infection Hypersensitivity to the drugs Those on immunosuppresive medications.

结局指标

主要结局

Improvement in PASI[Psoriasis Area and Severity Index] more than 75% from baseline

时间窗: 12 weeks

次要结局

  • Improvement in PASI[ PsoriasisArea and Severity Index](3 weeks,9 weeks)

研究者

发起方
RATHIPRIYADHARSHINI R
申办方类型
Other [self]

研究点 (1)

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