CTRI/2019/09/021078进行中（未招募）4 期
A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of Infimabâ„¢ in patients with moderate to severe plaque psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Incidence of adverse events occurring during the study
研究概览
简要总结
This prospective, multi-centre, open label, phase IV study has been designed to evaluate the safety and efficacy of InfimabTM in patients with moderate to severe plaque psoriasis.
InfimabTM has been approved by the regulatory authority in India for the treatment of plaque psoriasis.
研究设计
- 研究类型
- Observational
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 aged between 18 to 65 years (both inclusive).
- •Patients with confirmed diagnosis of plaque psoriasis since at least 6 months.
- •Patients with moderate to severe plaque psoriasis having PASI score >
- •Able to understand and willing to provide written informed consent.
排除标准
- •Patients with hypersensitivity to Infliximab or any of its components
- •Pregnant or lactating females
- •Presence of serious or active infection due to bacteria, fungi, viruses or other opportunistic pathogens
- •Patients with active or latent tuberculosis
- •Patients with history of any malignancy including lymphomas or presence of any premalignant lesions
- •Patients with heart failure (New York Heart Association class III or IV)
- •Patients with known hematological disorders, demyelinating disease or lupus-like syndrome
- •Patients with known clinically significant liver disease
- •Patients with any condition that might make it difficult for patients to participate in the study or that might affect interpretation of results of the study, at the discretion of Investigator.
- •Participation in any clinical study of an investigational product within previous 3 months.
- •Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study.
结局指标
主要结局
Incidence of adverse events occurring during the study
时间窗: Baseline to Week 14
次要结局
- Change in Psoriasis Area and Severity Index (PASI) score from baseline to week 14(From baseline to Week 14)
- Change in Physician Global Assessment (PGA) score from baseline to week 14(From baseline to Week 14)
研究者
研究点 (20)
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