A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)

Novartis Pharmaceuticals497 enrolled

Overview

This is a non-interventional, multi-country, Latin American study utilizing a prospective single-cohort design. Eligible CU patients will be enrolled in the study and will be followed for 24 months (± 6 weeks). In accordance with the observational nature of the study, there will be no interventions or interference with the routine care of the patient which will be based solely on the clinical judgment of the treating physician. However, with respect to the frequency and schedule of assessments, the schedule included in Table 7-1 will be recommended. The selection of the treatment for CU will be clearly separated from the decision to include the patient in the study, and will be made at the discretion of the treating physician in accordance with standard medical practice, the investigator's clinical judgment, and global urticarial guidelines. In order to prevent selection bias, investigators should offer enrollment to all consecutive patients meeting study criteria, likely to be available for the full duration of the follow-up period of 24 months, and willing to participate in the study. The overall objective of the study is to evaluate in real-life the CU disease burden, the current treatment patterns and the use of health care resources in patients refractory to H1-antihistamine treatment

Study Type

OBSERVATIONAL

Enrollment

497

Conditions

Chronic Urticaria

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Men or Women at least 18 years of age or older. Patient has medically confirmed diagnosis of chronic urticaria present for more than 2 months. Patient has been treated with at least one course of H1 antihistamines and is refractory to this treatment Patient has provided written informed consent allowing the use of their anonymous data for the purposes of the study Exclusion Criteria: Patient is currently participating in a clinical trial. Patient is, in the opinion of the treating physician, unlikely to be available for the full duration of the follow-up period of 24 months

Locations (31)

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Lobos, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Nueve De Julio, Argentina

Outcomes

Primary Outcomes

Change in CU-Quality of Life Questionnaire Score

The CU-QoL is a validated instrument with established psychometric properties developed specifically for the assessment of the health burden of CU. The 2013 international CU guideline recommends the use of CU-Q2oL for assessing quality of life impairment and monitoring disease activity.

Time frame: Last 15 days before each visit

Secondary Outcomes

Angioedema Quality of Life Questionnaire (AE-QoL)

For patients with angioedema, the symptom-specific quality of life will be assessed over the course of the study with the Angioedema Quality of Life Questionnaire (AE-QoL)

Time frame: Last 4 weeks before each visit

Change in Dermatology Life Quality Index (DLQI).

A 10-item dermatology-specific health-related quality-of-life measure assessing dermatology symptoms and their impact on various aspects of life, during the course of the study

Time frame: Last 7 days before each visit

Urticaria Activity Score for 7 days (UAS7)

Patients willing and able to comply with the UAS7 assessment will be given a paper-based urticaria diary at every site visit and be asked to complete it daily over the week preceding the next site visit. The diary consists of questions to evaluate the severity of their disease, and patients have to assess the severity of their disease, numbers of wheals and severity of itching

Time frame: Last 7 days before each visit

Angioedema Activity Score (AAS)

The Angioedema Activitiy Score (AAS) is a validated, easy to use tool to determine disease activity in patients with recurrent angioedema, independent of its underlying causes. The AAS is designed to be used by patients for their daily documentation of swelling episodes including their duration, severity and impact on daily functioning and appearance.

Time frame: Last 24 hours before each visit

Urticaria Control Test (UCT)

Short questionnaire assessing how well the urticaria symptoms were controlled over the last 4 weeks

Time frame: Last 4 weeks before each visit

6-item Work Productivity and Activity Impairment (WPAI) instrument

Respondents are asked questions about work and activity impairment due to health problems

Time frame: Last 7 days before each visit