NCT01187264已完成4 期
Efficacy and Safety of Methotrexate in 2 Fixed Doses of 10mg or 25mg Orally Once Weekly in Patients With Severe Plaque Type Psoriasis: a Prospective, Randomized, Double Blind, Dose Ranging Study
Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks
研究概览
简要总结
In this study the investigators intend to compare the efficacy and safety of two fixed doses of once weekly oral methotrexate in a prospective randomized double blind manner in patients with severe plaque type 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with plaque-type psoriasis having more than 10% body surface area involvement (severe psoriasis).20
- •Patients of either sex with age between 18-65 years.
- •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 and negative pregnancy test 2 weeks before starting of treatment and at day 2 or 3 of a normal menstrual cycle.
- •Males who were willing to maintain contraception during and 3 months after completion/stopping of treatment.
排除标准
- •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.
- •Active infectious disease or immune system deficiency including AIDS.
- •history of intolerance/hypersensitivity to methotrexate.
- •history of phototherapy in past 6 months.
- •Patients who had received any systemic treatment for psoriasis in the past 4 weeks and topical treatment in the past 2 weeks.
- •Body mass index (BMI) > 30 kg/m2.
研究组 & 干预措施
methotrexate 10 mg
Active Comparator
oral methotrexate 10 mg once weekly
干预措施: Methotrexate (Drug)
methotrexate 25mg
Active Comparator
oral methotrexate 25 mg once weekly
干预措施: Methotrexate (Drug)
结局指标
主要结局
change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks
时间窗: 12 weeks
次要结局
- time to achieve PASI 75(12 weeks or earlier)
- number of patients achieving PASI 90 and 100(12 weeks or earlier)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and PlaceboChronic Obstructive Pulmonary DiseaseNCT01049360AstraZeneca128
已完成
2 期
Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular GoiterMultinodular GoiterNCT00454220Genzyme, a Sanofi Company96
已完成
2 期
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal CancerNeutropeniaAnemiaThrombocytopeniaLymphopeniaNCT00771810Tarix Pharmaceuticals34
已完成
3 期
Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension.Essential HypertensionNCT05288400Servier150
已完成
2 期
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMDAMDWet AMDWet Age-Related Macular DegenerationEye DiseasesRetinal DiseasesMacular DegenerationAge-Related Macular DegenerationNCT01016873Oraya Therapeutics, Inc.230