A prospective, Post Marketing Surveillance study to study the safety and effectiveness of omalizumab in Indian patients with Chronic Spontaneous Urticaria refractory to standard of care
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 138
- 试验地点
- 11
- 主要终点
- To obtain safety data from Indian patients with Chronic Spontaneous Urticaria refractory to standard of care treated with omalizumab
研究概览
简要总结
The present post marketing surveillance (PMS) study is mandated by Indian health authority (HA) as a part of conditional approval to market authorization of omalizumab in CSU refractory to standard of care. The Health Authorities have mandated “PMS data for 2 years†in their approval letter. Due to non- availability of Indian data for Omalizumab in CSU patients, marketing authorization of the same has been granted condition to “submission of PMS data for 2 yearsâ€.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Thus the present prospective Post marketing Surveillance (PMS) study will be conducted to study the effect of omalizumab in Indian patients with Chronic Spontaneous Urticaria refractory to standard of care under current real-life medical practice as mandated by HA. The study evaluates safety (primary objective) and effectiveness (secondary objective) of omalizumab in CSU refractory to standard of care.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •CSU patients prescribed with omalizumab as per approved package insert and who are not treated with omalizumab 6 months prior to entering the study.
- •Patients willing to participate in the study by providing written informed consent.
排除标准
- •1.Contraindication as per PI.
- •2.Patients simultaneously participating in other studies Pregnant women should not be included except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus.
结局指标
主要结局
To obtain safety data from Indian patients with Chronic Spontaneous Urticaria refractory to standard of care treated with omalizumab
时间窗: study duration up to Month 24
次要结局
- Collect effectiveness data during real-world use of omalizumab in CSU(study duration up to Month 24)
- Provide real-world QoL data in patients with CSU treated with omalizumab(study duration up to Month 24)
- Assess CSU Indian patient’s journey treated with omalizumab in real world scenario.(study duration up to Month 24)