Study of effectiveness of methotrexate-pioglitazone combination compared to methotrexate alone in patients of plaque psoriasis with an attempt to revisit some relevant immunological perspectives

School of Tropical Medicine0 个研究点目标入组 80 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients between 18 -65 years of age (both inclusive) with clinical diagnosis of plaque psoriasis as determined through clinical examination.
•2. Patient should be a candidate for systemic therapy
•3. PASI (Psoriasis Area and Severity Index) score of >= 12 at the Baseline visit.
•4. Females who were postmenopausal or tubectomised or have completed their family size and are willing to maintain contraception 1 month before, during and 1 month after completion/stopping of treatment.
•5. Sexually active male subjects are able to participate in the study if they use effective contraception during the study and 3 months after study completion.
•6. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, and 12-lead electrocardiogram (ECG) performed at Screening.
•7. Able and willing to give written informed consent and to comply with the requirements of this study protocol.

•Pregnant or lactating women.
•Any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness.
•Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP >1.5 times the upper limit of normal), viral hepatitis or cirrhosis.
•History of excessive alcohol consumption.
•Severe anemia, leucopenia or thrombocytopenia.
•History of active infectious disease or immune system deficiency including AIDS.
•History of intolerance/hypersensitivity to methotrexate.
•Subjects who have used any investigational drugs within 4 weeks of Screening or are participating in other clinical studies

发起方

School of Tropical Medicine