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临床试验/NCT07337434
NCT07337434招募中1 期

Comparison of Efficacy of Methotrexate vs Apremilast in Moderate to Severe Plaque Psoriasis

Syeda Sana Zaman1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年12月25日最近更新:
干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
106
试验地点
1
主要终点
PASI SCORE calculation

研究概览

简要总结

This study aims to compare efficacy of methotrexate vs apremilast in the management of chronic plaque psoriasis.Given the high prevalence of psoriasis in Pakistan and the significant psychological impact on patients, particularly in Peshawer,this study will provide valuable insights into optimal treatment strategies.

详细描述

Introduction Plaque Psoriasis are red, scaly plaques which mostly manifests on the skin's extensor surfaces, are the hallmark of plaque psoriasis, a chronic inflammatory skin disorder. It significantly impairs patients' quality of life and poses therapeutic challenges due to chronicity and relapse tendency. Approximately 2% to 3% of the global population deals with psoriasis. The most frequent subtype of psoriasis, plaque psoriasis, affects between 0.5% to 1% of Pakistanis, according to research conducted in hospitals.

Patients with moderate to severe disease were traditionally treated with methotrexate-based systemic therapy. However, its long-term safety profile concerning hepatotoxicity and myelosuppression requires periodic monitoring. Apremilast, a newer oral phosphodiesterase-4 inhibitor, has demonstrated moderate efficacy with a favorable safety profile but is less commonly used in developing countries due to cost and limited availability.

While multiple studies have evaluated the efficacy of both drugs individually, direct head-to-head comparisons in regional populations are lacking. Recent international trials indicate Apremilast may have a better tolerability profile but lower efficacy compared to Methotrexate.Apremilast was reported to be more effective than methotrexate (47.3% vs 21.8%) in decreasing PASI scores over 12 weeks in a recent research involving 112 individuals with moderate to severe plaque psoriasis. Both therapies had minor adverse effects, but Apremilast was found to be more effective.

Despite methotrexate's extensive use in treating moderate to severe plaque psoriasis, concerns regarding its long-term safety and variable effectiveness persist. Apremilast, a newer oral agent, offers a favorable safety profile but is underutilized in resource-limited settings due to cost and limited availability. Few local studies have compared the two treatments using PASI and other standardized outcome measures to determine whether one is more effective. In light of the relative efficacy and safety of Methotrexate and Apremilast, it is imperative that Pakistani physicians have access to the findings of this trial so that they may make treatment decisions grounded in data.

Objective To compare the efficacy of methotrexate vs apremilast in moderate to severe plaque psoriasis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having age between 18-60 years of either gender Diagnosed with moderate to severe plaque psoriasis (PASI ≥10) No prior systemic therapy in past 3 months.

排除标准

  • Pregnancy or lactation History of liver or renal dysfunction Known hypersensitivity to study drugs

研究组 & 干预措施

Methotrexate

Experimental

This group will recieve methotrexate 10-25mg once weekly for 3 months,

干预措施: Methotrexate (Drug)

Apremilast

Experimental

This group will recieve apremilast 30mg BD for 3 months.

干预措施: Apremilast (Drug)

结局指标

主要结局

PASI SCORE calculation

时间窗: 3 months

Efficacy of drugs are measured by calculation of PASI score for both groups at each visit.A treatment will be deemed effective if it achieves 75% reduction in PASI score from the baseline in 12 weeks. Score ranges from 0 (no disease) to 72( maximums severity) Interpretation: 0-5 mild 6-10 moderate \>10 severe

次要结局

未报告次要终点

研究者

发起方
Syeda Sana Zaman
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Syeda Sana Zaman

Training medical officer

Hayat Abad Medical Complex, Peshawar

研究点 (1)

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