A prospective, Post Marketing Surveillance study of omalizumab in Chronic Spontaneous Urticaria
Phase 4
- Conditions
- Health Condition 1: null- Xolair in CS
- Registration Number
- CTRI/2015/10/006247
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. CSU patients prescribed with omalizumab as per approved package insert and who are not treated with omalizumab 6 months prior to entering the study.
2. Patients willing to participate in the study by providing written informed consent.
Exclusion Criteria
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To obtain safety data from Indian patients with Chronic Spontaneous Urticaria refractory to standard of care treated with omalizumabTimepoint: study duration up to Month 24
- Secondary Outcome Measures
Name Time Method Assess CSU Indian patientâ??s journey treated with omalizumab in real world scenario.Timepoint: study duration up to Month 24;Collect effectiveness data during real-world use of omalizumab in CSUTimepoint: study duration up to Month 24;Provide real-world QoL data in patients with CSU treated with omalizumabTimepoint: study duration up to Month 24