Effectiveness and Safety of Oral Methotrexate versus Oral tofacitinib in the Treatment of Chronic Plaque Psoriasis-A Randomized control trial

Rishana N1 个研究点分布在 1 个国家目标入组 96 人开始时间: 2024年8月23日最近更新: 2024年8月12日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 96
试验地点: 1
主要终点: PASI50

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Patients will be randomised into 2 groups â€“ group A and group B using a random sequence generated by Randomization software of Research randomizer.org.

Pre treatment Investigations â€“ CBC with ESR , CRP , Liver fuction test , Renal function test , Viral serology , FBS , HbA1c ,PPBS ,Sr. electrolytes, FLP , CXR â€“ PA view, Tuberculin skin test , ECG, Urine routine and Joint x ray ,screening ECHO.

GROUP A â€“ Oral MTX 7.5mg weekly once and T.FOLIC ACID 5mg od to be given on all days except the day of MTX administration.

GROUP B â€“ T.Tofacitinib 5mg twice daily.

Antihistamine will be administered to the patients other than the study drugs, for both the groups.

In both groups baseline PASI score , NAPSI score , ACR score, PGA score and Patient satisfaction score for 0,4th,8th,12th,16th and 20th weeks and clinical photographs will be taken.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Chronic plaque psoriasis with PASI more than
•Patient with nail psoriasis.
•Patient with Psoriatic arthritis.

排除标准

•Pregnancy and lactation.
•Females and males who were planning to have a child and not willing for using contraception.
•Systemic therapy taken for psoriasis in the past 4 weeks before enrolling into the study.
•Topical therapy taken for psoriasis in past 2 weeks before enrolling into the study.
•Acute or chronic liver disease or renal disease/ uncontrolled hypertension/ uncontrolled Diabetes mellitus.
•known allergy to any of the study drugs.
•Active infection such as Tuberculosis, HIV, Hepatitis B and C.
•History of disseminated herpes zoster or herpes simplex or recurrent localized dermatomal herpes zoster.