TCTR20181205001招募中3 期
Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis- An Open Label randomized Trial
Globe Pharmaceuticals Limited0 个研究点目标入组 60 人开始时间: 2018年12月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Male or female patients more than 18 years
- •Psoriatic arthritis > 3 months with peripheral involvement diagnosed on the basis of CASPAR criteria
- •Unresponsive to more than 2 NSAIDs at maximum recommended doses for more than 4 weeks, i.e 2 weeks for each NASID
- •Patients with active disease
- •PsA with or without extra-articular features like enthesitis, dactylitis and nail changes
排除标准
- •Systemic infections requiring hospital admission during the past 6 months
- •A history of active infectious disorders (including active or latent tuberculosis), and/or a history of chronic or recurrent serious infective diseases, opportunistic infections
- •Hemoglobin (Hb) < 9 g/dl
- •White blood cell count < 3000, Neutrophil count < 1000, Platelet count < 100000
- •Live vaccines within 3 months prior to the first dose
- •Serum creatinine > upper limit of normal reference range
- •GFR less than 50 mL/min
- •Alanine aminotransaminase (ALT) more than 2 times of ULN
- •Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
- •New York Heart Association Class III and IV congestive heart failure
- •Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ
- •Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease
研究者
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