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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- •The change in PASI (Psoriasis Area and Severity Index) scores of the patients as measured at baseline and at week 12.
研究概览
简要总结
Psoriasis is a chronic, inflammatory, immune mediated skin disorder.The present piece of work aims to evaluate the effectivenessof methotrexate -pioglitazone combination versus methotrexate in plaque psoriasis patients.Besides this, an effort will be made to elucidate impact of the abovementioned two treatment regimens on some selected immunologic parameters. An openlabel, parallel design, randomized clinical trial will be conducted at the Calcutta School of Tropical Medicine to address the abovementioned study objectives.Effectiveness of the two treatment regimens will be assessed in terms of relative changes in efficacy, safety and quality of life in either group measured at baseline and after 12 weeks of treatment.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 18 -65 years of age (both inclusive) with clinical diagnosis of plaque psoriasis as determined through clinical examination.
- •Patient should be a candidate for systemic therapy
- •PASI (Psoriasis Area and Severity Index) score of ≥ 12 at the Baseline visit.
- •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.
- •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.
- •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.
- •Able and willing to give written informed consent and to comply with the requirements of this study protocol.
排除标准
- •â€¢Pregnant or lactating women.
- •â€¢Any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness.
- •â€¢Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP >1.5 times the upper limit of normal), viral hepatitis or cirrhosis.
- •â€¢History of excessive alcohol consumption.
- •â€¢Severe anemia, leucopenia or thrombocytopenia.
- •â€¢History of active infectious disease or immune system deficiency including AIDS.
- •â€¢History of intolerance/hypersensitivity to methotrexate.
- •â€¢Subjects who have used any investigational drugs within 4 weeks of Screening or are participating in other clinical studies.
结局指标
主要结局
•The change in PASI (Psoriasis Area and Severity Index) scores of the patients as measured at baseline and at week 12.
时间窗: 12 weeks
次要结局
- The change in Physicians Global Assessment (PGA) Score of the patients as measured at baseline and at week 12.
- Serum level of certain cytokines in patients at baseline and at 12 weeks(12 weeks)