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临床试验/CTRI/2019/04/018854
CTRI/2019/04/018854尚未招募Unknown

Comparison of the efficacy of Methotrexate (Mtx) and Apremilast (Apr) in psoriasis

Yenepoya Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月5日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the efficacy of Methotrexate and Apremilast

研究概览

简要总结

The study desigin is Quasi experimental study. Primary objective of the study will be to compare the efficacy of Methotrexate and Apremilast in patients with Psoriasis and to compare the adverse effects associated with both the drugs. Patients diagnosed with psoriasis attending the Dermatology OPD in Yenepoya Medical College Hospital, Mangalore will be enrolled for the study. Eligible patients with Psoriasis will be treated with Methotrexate or Apremilast. Outcome will be measured at the end of treatment.  Clinical evaluation will be done for every patients.Psoriasis area severity index (PASI) will be calcilated. Blood investigations like complete blood picture, Liver function test will be done in all subjects as required for treatment. Every alternative patient will be put on either Methotrexate or Apremilast. Methotrexate will be given 7.5 mg/week orally with requisite clinical and laboratory monitoring. Weekly monitoring for first month or as required. Apremilast will be given 30 mg BID orally. Initially dose will be titrated from 10 mg/ day with gradually increasing to 30 mg BID over a week. Patient will be evaluated every month for 4 months. Patient is not supposed to use any topical treatment other than emollients during study time.This study will highlight the advantages of the less commonly used drug for treatment of psoriasis. Apremilast does not require frequent monitoring compared to Methotrexate and improves the quality of life in patients.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •All patients visiting the Dermatology OPD diagnosed to have Psoriasis who needs systemic therapy.
  • •Patients requiring and willing to undergo treatment with Methotrexate or Apremilast.

排除标准

  • 1.Patients who have taken systemic therapy in past three months or topical treatment or phototherapy in past 2 weeks 2.Who are lesser than 18 years of age.
  • 3.Pregnant or those having any serious illness contraindicating systemic therapy.

结局指标

主要结局

To compare the efficacy of Methotrexate and Apremilast

时间窗: 4 months

次要结局

  • To compare the side effects of Methotrexate and Apremilast(4 months)

研究者

申办方类型
Private medical college

研究点 (1)

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