NCT01373567已完成4 期
An Open Label, Non-comparative, Multicentre, Phase IV Study to Evaluate the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 23
- 主要终点
- Change in Psoriasis area severity index score
研究概览
简要总结
Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting approximately 2% of the world's population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from psoriasis under conditions of actual use and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients treated with Tinefcon. This study will add to literature on the risks and benefits of Tinefcon the novel oral TNF-alpha release inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of at least 18 years of age with clinical diagnosis of plaque psoriasis
- •Subject who understand and willing to sign informed consent document before start of any study specific assessment
排除标准
- •Pregnant and lactating females
- •Subject with active infection, acute or chronic due to bacteria, viruses, fungi or parasites (most notably tuberculosis, and chronic hepatitis B)
- •Subject with heart failure (New York Heart Association class III or IV)
- •Subject with demyelinating disease
- •Subject with solid cancer or hematologic malignancy diagnosed within last 5 years with a potential for progression
- •Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) after signing an informed consent document (ICD), during the duration of study participation and for at least 4 week after withdrawal from the study, unless they are surgically sterilized
- •Subject with situations associated with a high risk of infection such as latent untreated tuberculosis, joint prosthesis infection within last 12 months, indwelling urinary catheter, uncontrolled diabetes, chronic obstructive pulmonary disease, skin ulcer
- •Subject with known premalignant lesions (such as polyps in the colon or urinary bladder, cervical dysplasia and myelodysplasia)
- •Subject known to be seropositive and/or clinically suspected to have the human immunodeficiency virus infection
- •Subject with any condition that might make it difficult for the subject to participate in the study, at the discretion of the Investigator.
研究组 & 干预措施
TINEFCON
Experimental
Tablets of 700 mg.
干预措施: TINEFCON (Drug)
结局指标
主要结局
Change in Psoriasis area severity index score
时间窗: At week 4, week 8 and week 12 or early termination
Change from baseline at week 4, week 8 and week 12 or early termination
次要结局
- Gene expression profiling and Immunohistochemistry(At baseline and week 12 or early termination)
- Physicians global assessment score(At week 4, week 8 and week 12 / early termination visit)
- Nail psoriasis severity index(At baseline and at week 12 or early termination)
- Psoritic arthritis evaluation(At baseline and week 12 or early termination)
研究者
研究点 (23)
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