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临床试验/CTRI/2022/01/039825
CTRI/2022/01/039825尚未招募不适用

Comparative study of oral Methotrexate vs oral Methotrexate along with Apremilast in patients with Moderate to Severe Chronic Plaque Psoriasis

GMERS Medical College and CIvil Hospital Sola1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1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
30
试验地点
1
主要终点
2. To access clinical improvement based on clinical photographs and PASI score

研究概览

简要总结

Psoriasis is a chronic inflammatory cutaneous disorder, affecting up to 2%-5% of the world population. The major manifestation of psoriasis is erythematous, scaly patches or plaques on the skin that are occasionally pruritic but have a significant impact on patient’s Quality of Life due to chronicity of the disease and frequent remissions and relapses. Psoriasis is a predominantly a T-cell mediated disorder occurring in genetically susceptible individuals, influenced by environmental factors. Methotrexate is a standard, cheaper drug for psoriasis with excellent efficacy but limited safety profile while Apremilast is a newer molecule with excellent safety profile. Comparing the standard drug alone with addition of newer drug will help in identifying better treatment options for psoriasis in terms of efficacy and safety in a disease which requires long term treatment. Methotrexate acts on cell cycle so have higher side effects like Neutropenia, Bone marrow suppression, Liver fibrosis, etc. Apremilast is a biologic which acts via Cyclic AMP pathway. So it has lesser toxicity and side effects than methotrexate. Apremilast can cause increase URTI, Flu-like symptoms in few patients. Apremilast is out of reach for common people because of its prohibiting cost. But nowadays this drug is not that costly. So adding oral Apremilast in Patients with moderate to severe psoriasis, dose of the Methotrexate can be reduced and can be stopped early and low dose oral Apremilast will be continued for a longer time. Whenever disease exacerbates, we can either increase the dose of oral Apremilast or add oral Methotrexate to control the activity. So over long run cumulative dose of Methotrexate can be reduced and toxicity can be decreased.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients ready to be part of study and sign ICF.
  • Patient presenting with Moderate to Severe Chronic Plaque Psoriasis according to the Rule of Tens (PASI score >10).

排除标准

  • Patients who failed to give written consent.
  • In patients in which Methotrexate and/or Apremilast is contraindicated
  • Pregnant women and Lactating Mothers
  • Patients with mild disease (PASI <10)
  • Erythrodermic or pustular psoriasis, predominant scalp or nail involvement
  • Patients who have taken methotrexate continuously or intermittently in more than 2.5gm total dose.
  • Patients with hepatic or renal impairment, cardiac dysfunction, blood dyscrasias or any other systemic comorbidity.

结局指标

主要结局

2. To access clinical improvement based on clinical photographs and PASI score

时间窗: Baseline, then monthly upto 4 months

3. To assess the dose requirement of methotrexate in both groups.

时间窗: Baseline, then monthly upto 4 months

1. To study the efficacy of oral Methotrexate vs oral Methotrexate with Apremilast in patients with moderate to severe chronic plaque psoriasis

时间窗: Baseline, then monthly upto 4 months

次要结局

  • 1. To compare the DLQI in both the study groups(2. To study the safety profile of study drugs.)

研究者

发起方
GMERS Medical College and CIvil Hospital Sola
申办方类型
Government medical college

研究点 (1)

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