A prospective, Post Marketing Surveillance study of omalizumab in Chronic Spontaneous Urticaria

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/10/006247

Enrollment

138

Registered

2015-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Xolair in CSU

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Venkatramana Nagire

Novartis Healthcare Pvt. Ltd

venkatramana.nagire@novartis.com24958562

Outcome results